70 FR 188 pgs. 56911-56925 - Medical Devices; Reprocessed Single-Use Devices; Termination of Exemptions From Premarket Notification; Requirement for Submission of Validation Data
Type: NOTICEVolume: 70Number: 188Pages: 56911 - 56925
Docket number: [Docket No. 2003N-0161] (formerly Docket No. 03N-0161)
FR document: [FR Doc. 05-19510 Filed 9-28-05; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0161] (formerly Docket No. 03N-0161)
Medical Devices; Reprocessed Single-Use Devices; Termination of Exemptions From Premarket Notification; Requirement for Submission of Validation Data
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is adding noncompression heart stabilizers to the list of critical reprocessed single-use devices (SUDs) whose exemption from premarket notification requirements has been terminated and for which validation data, as specified under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), are necessary in a premarket notification (510(k)). The agency is also adding laparoscopic and endoscopic electrosurgical accessories to the list of reprocessed SUDs currently subject to premarket notification requirements that will now require submission of supplemental validation data. FDA is requiring submission of these data to ensure that reprocessed single-use noncompression heart stabilizers and laparoscopic and endoscopic electrosurgical accessories are substantially equivalent to predicate devices, in accordance with MDUFMA.
DATES:
These actions are effective September 29, 2005. Manufacturers of reprocessed single-use noncompression heart stabilizers must submit 510(k)s for these devices by December 29, 2006, or their devices may no longer be legally marketed. Manufacturers of reprocessed single-use laparoscopic and endoscopic electrosurgical accessories who already have 510(k) clearance for these devices must submit supplemental validation data for the devices by June 29, 2006, or their devices may no longer be legally marketed.
ADDRESSES:
Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments . Comments should be identified with the docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Barbara A. Zimmerman, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8320, ext. 158.
SUPPLEMENTARY INFORMATION:
I. Background
On October 26, 2002, MDUFMA (Public Law 107-250), amended the Federal Food, Drug, and Cosmetic Act (the act) by adding section 510(o) (21 U.S.C. 360(o)), which provided new regulatory requirements for reprocessed SUDs. According to this new provision, in order to ensure that reprocessed SUDs are substantially equivalent to predicate devices, 510(k)s for certain reprocessed SUDs identified by FDA must include validation data. These required validation data include cleaning and sterilization data, and functional performance data demonstrating that each SUD will remain substantially equivalent to its predicate device after the maximum number of times the device is reprocessed as intended by the person submitting the premarket notification.
Before enactment of the new law, a manufacturer of a reprocessed SUD was required to obtain premarket approval or premarket clearance for the device, unless the device was exempt from premarket submission requirements. Under MDUFMA, some previously exempt reprocessed SUDs are no longer exempt from premarket notification requirements. Manufacturers of these identified devices were required to submit 510(k)s that included validation data specified by FDA. Reprocessors of certain SUDs already subject to cleared 510(k)s were also required to submit the validation data specified by the agency.
The reprocessed SUDs subject to these new requirements were listed in the Federal Register as required by MDUFMA. In accordance with section 510(o) of the act, FDA shall revise the lists as appropriate. This notice adds two types of reprocessed SUDs to the lists of devices subject to MDUFMA's data submission requirements. Noncompression heart stabilizers are being added to the list of previously exempt reprocessed SUDs that now require the submission of 510(k)s containing validation data. Laparoscopic and endoscopic electrosurgical accessories are being added to the list of reprocessed SUDs, already subject to premarket notification requirements, for which supplemental validation data are required.
A. Definitions
Under section 302(b) of MDUFMA, a reprocessed SUD is defined as an "original device that has previously been used on a patient and has been subjected to additional processing and manufacturing for the purpose of an additional single use on a patient. The subsequent processing and manufacture of a reprocessed single-use device shall result in a device that is reprocessed within the meaning of this definition."
Reprocessed SUDs are divided into three groups: (1) critical, (2) semicritical, and (3) noncritical. The first two categories reflect definitions set forth in MDUFMA, and all three reflect a classification scheme recognized in the industry.1 These categories of devices are defined as follows:
Footnotes:
1 Spaulding, E.H., "The Role of Chemical Disinfection in the Prevention of Nonsocomial Infections," P.S. Brachman and T.C. Eickof (ed), Proceedings of International Conference on Nonsocomial Infections, 1970, American Hospital Association, Chicago, 254-274, 1971.
(1) A critical reprocessed SUD is intended to contact normally sterile tissue or body spaces during use.
(2) A semicritical reprocessed SUD is intended to contact intact mucous membranes and not penetrate normally sterile areas of the body.
(3) A noncritical reprocessed SUD is intended to make topical contact and not penetrate intact skin.
B. Critical and Semicritical Reprocessed SUDs Previously Exempt From Premarket Notification
MDUFMA required FDA to review the critical and semicritical reprocessed SUDs that were previously exempt from premarket notification requirements and determine which of these devices required premarket notification to ensure their substantial equivalence to predicate devices. By April 26, 2003, FDA was required to identify in a Federal Register notice those critical reprocessed SUDs whose exemption from premarket notification would be terminated and for which FDA determined that validation data, as specified under MDUFMA, was necessary in a 510(k). According to the law, manufacturers of the devices whose exemptions from premarket notification were terminated were required to submit 510(k)s that included validation data regarding cleaning, sterilization, and functional performance, in addition to all the other required elements of a 510(k) identified in § 807.87 (21 CFR 807.87), within 15 months of publication of the notice or no longer market their devices.
In accordance with section 510(o) of the act, FDA must revise the list of devices subject to this requirement as appropriate. On June 26, 2003 (68 FR 38071), FDA recategorized nine device types from semicritical to critical, and added nonelectric gastroenterology-urology biopsy forceps to the list of critical devices whose exemption from premarket notification requirements was being terminated.
By April 26, 2004, FDA was required to identify in a Federal Register notice those semicritical reprocessed SUDs whose exemption from premarket notification would be terminated and for which FDA determined that validation data, as specified under MDUFMA, was necessary in a 510(k). As discussed above, manufacturers of the devices whose exemptions from premarket notification were terminated were required to submit 510(k)s that included validation data regarding cleaning, sterilization, and functional performance, in addition to all the other required elements of a 510(k) identified in § 807.87, within 15 months of publication of the notice or no longer market their devices. In accordance with section 510(o) of the act, FDA must revise the list of devices subject to this requirement as appropriate.
C. Reprocessed SUDs Already Subject to Premarket Notification Requirements
MDUFMA also required FDA to review the types of reprocessed SUDs already subject to premarket notification requirements and to identify which of these devices required the submission of validation data to ensure their substantial equivalence to predicate devices. FDA published a list of these devices in the Federal Register on April 30, 2003 (68 FR 23139). As described above, FDA must revise the list of devices subject to this requirement as appropriate.
For devices identified on this list that had already been cleared through the 510(k) process, manufacturers were required to submit validation data regarding cleaning, sterilization, and functional performance within 9 months of publication of the list or no longer market their devices.
For devices on this list that were not yet cleared through the 510(k) process, manufacturers were required to submit 510(k)s including validation data regarding cleaning, sterilization, and functional performance, in addition to all the other required elements identified in 21 CFR 807.87, in order to market these devices.
II. FDA's Implementation of New Section 510(o) of the Act
In the Federal Register of April 30, 2003 (68 FR 23139), FDA described the methodology and criteria used to identify the reprocessed SUDs that were included in the lists required by MDUFMA. First, FDA described how it identified the types of SUDs currently being reprocessed and how the Spaulding definitions (see footnote 1) were used to categorize these devices as critical, semicritical, or noncritical. (See Attachment 1.) Next, the agency described its use of the Risk Prioritization Scheme (RPS)2 that was used to evaluate the potential risk (high, moderate, or low) associated with an SUD based on the following factors: (1) Risk of infection and (2) risk of inadequate performance following reprocessing. FDA identified its final criterion as those reprocessed SUDs intended to come in contact with tissue at high risk of being infected with the causative agents of Creutzfeldt-Jakob Disease (CJD). (These are generally devices intended for use in neurosurgery and ophthalmology.)
Footnotes:
2 This scheme is described in the February 2000 draft guidance document entitled, "Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme." http://www.fda.gov/cdrh/reuse/1156.html .
Using this methodology and these criteria, the devices included on List I (Critical and Semicritical Reprocessed SUDs Previously Exempt from Premarket Notification Requirements that Now Require 510(k)s with Validation Data) of the April 30, 2003, June 26, 2003, and April 13, 2004, Federal Register notices are those critical and semicritical reprocessed SUDs that were either high risk according to the RPS or intended to come in contact with tissue at high risk of being infected with CJD. The devices included on List II (Reprocessed SUDs Subject to Premarket Notification Requirements that Now Require the Submission of Validation Data) of the April 30, 2003, Federal Register notice are those reprocessed SUDs already subject to premarket notification requirements that were either high risk according to the RPS or intended to come in contact with tissue at high risk of being infected with CJD.
III. Revisions to Attachment 1, List I, and List II
A. Revisions to Attachment 1 (List of SUDs Known To Be Reprocessed or Considered for Reprocessing)
FDA has evaluated the comments received regarding section 510(o) of the act. In doing so, the agency has determined that all noncompression heart stabilizers and endoscopic and laparoscopic electrosurgical accessories should be considered high risk devices when reprocessed.
Noncompression heart stabilizers are intended to move, lift, and position the heart while maintaining hemodynamic stability during cardiovascular surgery. The agency has determined that noncompression heart stabilizers are high risk devices when reprocessed because they include features, such as narrow tubing, interlocking parts, and small crevices that could impede cleaning and sterilization and because these devices contain materials, coatings, or components that may be damaged or altered by reprocessing. Therefore, these devices have the potential for a high risk of infection and/or inadequate performance when reprocessed. This includes noncompression heart stabilizers (device 21 in Attachment 1) classified under § 870.4500 (21 CFR 870.4500). In determining that noncompression heart stabilizers are high risk devices when reprocessed, a new product code has been created to identify these devices within regulation § 870.4500. The new product code is NQG. This new product code has been added to device 21 in Attachment 1 of this document.
Endoscopic and laparoscopic electrosurgical accessories are surgical instruments used during minimally invasive surgery, including vein harvesting. The agency has determined that these devices should be considered high risk devices when reprocessed because they include features, such as narrow lumens, that could impede thorough cleaning and sterilization and because these devices contain materials, coatings, or components that may be damaged or altered by reprocessing. Therefore, these devices have the potential for a high risk of infection or inadequate performance when reprocessed. This includes endoscopic and laparoscopic electrosurgical accessories (device 162 in Attachment 1) classified under § 878.4400 (21 CFR 878.4400). In determining that endoscopic and laparoscopic electrosurgical accessories are potentially high risk devices when reprocessed, a new product code has been created to identify these devices within regulation § 878.4400. The new product code is NUJ. This new product code has been added to device 162 in Attachment 1.
These changes are reflected in a revised version of Attachment 1 included in this Federal Register notice.
B. Revisions to List I (Critical and Semicritical Reprocessed Single-Use Devices Previously Exempt from Premarket Notification Requirements that Now Require 510(k)s with Validation Data)
Using the RPS, FDA has recategorized noncompression heart stabilizers from moderate risk to high risk when reprocessed, and the agency has therefore added noncompression heart stabilizers to List I. Manufacturers of noncompression heart stabilizers will be required to submit 510(k)s with validation data by December 29, 2006, which is 15 months following this revision of the list.
To help reprocessors be able to easily identify those critical and semicritical reprocessed SUDs that have been categorized into List I in this notice and previous Federal Register notices, FDA is re-issuing a complete listing of these devices. Therefore, List 1 now identifies all critical and semicritical reprocessed SUDs previously exempt from premarket notification requirements that now require 510(k)s with validation data.
C. Revisions to List II (Reprocessed Single-Use Devices Subject to Premarket Notification Requirements that Now Require the Submission of Validation Data)
Using the RPS, FDA has recategorized endoscopic and laparoscopic electrosurgical accessories under regulation § 878.4400 from moderate risk to high risk when reprocessed. Therefore, endoscopic and laparoscopic electrosurgical accessories have been added to List II. Under MDUFMA, manufacturers of these devices who have already obtained clearance through the 510(k) process must submit validation data regarding cleaning, sterilization, and functional performance by June 29, 2006, which is 9 months following this revision of the list. Upon publication of this notice, manufacturers who have not yet obtained clearance through the 510(k) process must submit 510(k)s including validation data regarding cleaning, sterilization, and functional performance, in addition to all the other required elements of a 510(k) identified in 21 CFR 807.87, in order to market these devices.
| 21 CFR No. | Classification name | Product code for nonreprocessed device | Product code for reprocessed device | Product code name for reprocessed device |
|---|---|---|---|---|
| 868.6810 | Tracheobronchial suction catheter | BSY | NQV | Tracheobronchial suction catheter |
| 870.4500 | Cardiovascular surgical instruments | MWS | NQG | Noncompression heart stabilizer |
| 872.3240 | Dental bur | Diamond coated | NME | Dental diamond coated bur |
| 872.4535 | Dental diamond instrument | DZP | NLD | Dental diamond instrument |
| 872.4730 | Dental injection needle | DZM | NMW | Dental needle |
| 872.5410 | Orthodontic appliance and accessories | EJF | NQS | Orthodontic metal bracket |
| 874.4140 | Ear, nose, and throat bur | Microdebrider | NLY | ENT high speed microdebrider |
| 874.4140 | Ear, nose, and throat bur | Diamond coated | NLZ | ENT diamond coated bur |
| 874.4420 | Ear, nose, throat manual surgical .. | KAB, KBG, KCI | NLB | Laryngeal, sinus, tracheal trocar |
| 876.1075 | Gastroenterology-urology biopsy instrument | FCL | NON | Nonelectric biopsy forceps |
| 876.4680 | Ureteral stone dislodger | FGO, FFL | NQT, NQU | Flexible and basket stone dislodger |
| 878.4200 | Introduction/drainage catheter and accessories | GCB | NMT | Catheter needle |
| 878.4800 | Manual surgical instrument | MJG | NNA | Percutaneous biopsy device |
| 878.4800 | Manual surgical instrument | FHR | NMU | Gastro-Urology needle |
| 878.4800 | Manual surgical instrument for ... .... | DWO | NLK | Cardiovascular biopsy needle |
| 878.4800 | Manual surgical instrument for... | GAA | NNC | Aspiration and injection needle |
| 882.4190 | Forming/cutting clip instrument | HBS | NMN | Forming/cutting clip instrument |
| 884.1730 | Laparoscopic insufflator, .. | HIF | NMI | Laparoscopic insufflator and accessories |
| 884.4530 | OB/GYN specialized manual instrument | HFB | NMG | Gynecological biopsy forceps |
| 886.4350 | Manual ophthalmic surgical instrument | HNN | NLA | Ophthalmic knife |
| 21 CFR No. | Classification name | Product code for nonreprocessed device | Product code for reprocessed device | Product code name for reprocessed device |
|---|---|---|---|---|
| Unclassified | Oocyte aspiration needles | MHK | NMO | Oocyte aspiration needles |
| Unclassified | Percutaneous transluminal angioplasty catheter | LIT | NMM | Transluminal peripheral angioplasty catheter |
| Unclassified | Ultrasonic surgical instrument | LFL | NLQ | Ultrasonic scalpel |
| 868.5150 | Anesthesia conduction needle | BSP | NNH | Anesthetic conduction needle (with/without introducer) |
| 868.5150 | Anesthesia conduction needle | MIA | NMR | Short term spinal needle |
| 868.5730 | Tracheal tube | BTR | NMA | Tracheal tube (with/without connector) |
| 868.5905 | Noncontinuous ventilator (IPPB) | BZD | NMC | Noncontinuous ventilator (respirator) mask |
| 870.1200 | Diagnostic intravascular catheter | DQO | NLI | Angiography catheter |
| 870.1220 | Electrode Recording Catheter | DRF | NLH | Electrode recording catheter |
| 870.1220 | Electrode Recording Catheter | MTD | NLG | Intracardiac mapping catheter |
| 870.1230 | Fiberoptic oximeter catheter | DQE | NMB | Fiberoptic oximeter catheter |
| 870.1280 | Steerable Catheter | DRA | NKS | Steerable Catheter |
| 870.1290 | Steerable catheter control system | DXX | NKR | Steerable catheter control system |
| 870.1330 | Catheter guide wire | DQX | NKQ | Catheter guide wire |
| 870.1390 | Trocar | DRC | NMK | Cardiovascular trocar |
| 870.1650 | Angiographic injector and syringe | DXT | NKT | Angiographic injector and syringe |
| 870.1670 | Syringe actuator for injector | DQF | NKW | Injector for actuator syringe |
| 870.2700 | Oximeter | MUD | NMD | Tissue saturation oximeter |
| 870.2700 | Oximeter | DQA | NLF | Oximeter |
| 870.3535 | Intra-aortic balloon and control system | DSP | NKO | Intra-aortic balloon and control system |
| 870.4450 | Vascular clamp | DXC | NMF | Vascular clamp |
| 870.4885 | External vein stripper | DWQ | NLJ | External vein stripper |
| 872.5470 | Orthodontic Plastic Bracket | DYW | NLC | Orthodontic Plastic Bracket |
| 874.4680 | Bronchoscope (flexible or rigid) and accessories | BWH | NLE | Bronchoscope (nonrigid) biopsy forceps |
| 876.1075 | Gastro-Urology biopsy instrument | FCG | NMX | G-U biopsy needle and needle set |
| 876.1075 | Gastroenterology-urology biopsy instrument | KNW | NLS | Biopsy instrument |
| 876.1500 | Endoscope and accessories | FBK, FHP | NMY | Endoscopic needle |
| 876.1500 | Endoscope and accessories | MPA | NKZ | Endoilluminator |
| 876.1500 | Endoscope and accessories | GCJ | NLM | General and plastic surgery laparoscope |
| 876.1500 | Endoscope and accessories | FHO | NLX | Spring-loaded pneumoperitoneum needle |
| 876.4300 | Endoscopic electrosurgical unit and accessories | FAS | NLW | Active Urological electrosurgical electrode |
| 876.4300 | Endoscopic electrosurgical unit and accessories | FEH | NLV | Flexible suction coagulator electrode |
| 876.4300 | Endoscopic electrosurgical unit and accessories | KGE | NLU | Electric biopsy forceps |
| 876.4300 | Endoscopic electrosurgical unit and accessories | FDI | NLT | Flexible snare |
| 876.4300 | Endoscopic electrosurgical unit and accessories | KNS | NLR | Endoscopic (with or without accessories) Electrosurgical unit |
| 876.5010 | Biliary catheter and accessories | FGE | NML | Biliary catheter |
| 876.5540 | Blood access device and accessories | LBW | NNF | Single needle dialysis set (co-axial flow) |
| 876.5540 | Blood access device and accessories | FIE | NNE | Fistula needle |
| 876.5820 | Hemodialysis systems and accessories | FIF | NNG | Single needle dialysis set with uni-directional pump |
| 878.4300 | Implantable clip | FZP | NMJ | Implantable clip |
| 878.4400 | Electrosurgical Cutting and Coagulation Device and Accessories | GEI | NUJ | Endoscopic and laparoscopic electrosurgical accessories |
| 878.4750 | Implantable staple | GDW | NLL | Implantable staple |
| 880.5570 | Hypodermic single lumen needle | FMI | NKK | Hypodermic single lumen needle |
| 880.5860 | Piston Syringe | FMF | NKN | Piston Syringe |
| 882.4300 | Manual cranial drills, burrs, trephines and accessories | HBG | NLO | (Manual) drills, burrs, trephines and accessories |
| 882.4305 | Powered compound cranial drills, burrs, trephines . | HBF | NLP | (Powered, compound) drills, burrs, trephines and accessories |
| 882.4310 | Powered simple cranial drills, burrs, trephines . | HBE | NLN | (Simple, powered) drills, burrs, trephines and accessories |
| 884.1720 | Gynecologic laparoscope and accessories | HET | NMH | Gynecologic laparoscope (and accessories) |
| 884.6100 | Assisted reproduction needle | MQE | NNB | Assisted reproduction needle |
| 886.4370 | Keratome | HMY, HNO | NKY | Keratome blade |
| 886.4670 | Phacofragmentation system | HQC | NKX | Phacoemulsification needle |
| 892.5730 | Radionuclide brachytherapy source | IWF | NMP | Isotope needle |
| 1 Hemodialyzers have been excluded from this list because the reuse of hemodialyzers is addressed in "Draft Guidance for Hemodialyzer Reuse Labeling" October 6, 1995. An archived copy may be obtained from CDRH's Division of Small Manufacturers, International, and Consumer Assistance, please contact dsmica@cdrh.fda.gov . | ||||
IV. Stakeholder Input
In the Federal Register of February 4, 2003 (68 FR 5643), FDA invited interested persons to provide information and share views on the implementation of MDUFMA. Since that time, the agency has received comments on various MDUFMA provisions, including several on its implementation of section 510(o) of the act. As discussed above, one comment recommended that heart stabilizers should be considered high risk because of the risk of cross contamination and deterioration of the mechanical properties of the device. FDA agrees that noncompression heart stabilizers, a subset of all heart stabilizers, should be added to the list of critical reprocessed SUDs previously exempt from premarket notification requirements that will now require 510(k)s with validation data. Therefore, FDA has added noncompression heart stabilizers to List I.
Another comment recommended that FDA recategorize endoscopic vessel harvesting devices as high risk to be consistent with the categorization of other endoscopic accessories under 21 CFR 876.1500 (Endoscope and accessories). FDA agrees that endoscopic vessel harvesting devices should be considered high risk and subject to the submission of validation data. As discussed previously, in reviewing this comment, the agency also determined that laparoscopic electrosurgical accessories should be similarly categorized. Therefore, FDA has added laparoscopic and endoscopic electrosurgical accessories to List II.
Other additional comments requested that specific reprocessed SUDs be added to either List I or II. Each of these comments was carefully considered. However, FDA does not believe, based on the risk-based approach described in the April 30, 2003, Federal Register notice, that SUDs other than those identified in this notice should be added to the Lists at this time.
Another comment requested the FDA to call for the immediate submission and review of validation data regarding cleaning, sterilization, and functional performance for all reprocessed SUDs. The comment further stated that this request was based on the significant number of reprocessed devices which were withdrawn or were deemed to be insufficiently supported by validation data as of February 8, 2005.
Section 510(o) of the act required FDA to identify those reprocessed SUDs for which validation data must be submitted in order to ensure that those SUDs remain substantially equivalent to predicate devices after reprocessing. Because the agency has found that some reprocessed SUDs do not require the submission and review of validation data in order to demonstrate substantial equivalence, the agency identified the types of devices requiring the submission of validation data by implementing a risk-based approach. This risk-based approach, described in the April 30, 2003, Federal Register notice, identified a significant number of reprocessed SUDs that can no longer be legally marketed without agency review and clearance of validation data. The failure of some manufacturers to submit this validation data and the agency's review of submitted data resulted in a determination that a significant number of reprocessed SUDs could no longer be legally marketed. However, the process also identified a significant number of reprocessed SUDs that could continue to be marketed because: (1) they were found not to require the submission of additional validation data in order to ensure substantial equivalence to legally marketed predicate devices; or (2) after a review of submitted validation data, they were found to be substantially equivalent to legally marketed predicate devices. Therefore, FDA does not intend to expand the list of reprocessed SUDs subject to the submission and review of validation data to all reprocessed SUDs as requested in the comment. The agency believes it has implemented section 510(o) of the act by identifying the types of devices that require the submission of validation data and determining which of those devices can no longer be legally marketed.
V. Comments
You may submit written or electronic comments on the designation of reprocessed noncompression heart stabilizers and laparoscopic and endoscopic electrosurgical devices requiring the submission of premarket notifications with validation data to the Division of Dockets Management (see ADDRESSES ). Submit electronic comments to http://www.fda.gov/dockets/ecomments . Submit two copies of mailed comments, but individuals may submit one copy. You should identify your comments with the docket number found in brackets in the heading of this document. You may see any comments FDA receives in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
| Medical Specialty | Device Type | Regulation Number | Class | Product Code | RiskA | Critical/Semicritical/Noncritical | Premarket Exempt | |
|---|---|---|---|---|---|---|---|---|
| 1 | Cardio | Cardiopulmonary Bypass Marker | Unclassified | MAB | 1 | C | N | |
| 2 | Cardio | Percutaneous Operative Transluminal Coronary Angioplasty Catheter (PTCA) | Post-amendment | III | LOX | 3 | C | N |
| 3 | Cardio | Percutaneous Ablation Electrode | Post-amendment | III | LPB | 3 | C | N |
| 4 | Cardio | Peripheral Transluminal Angioplasty (PTA) Catheter | 870.1250 | II | LIT | 3 | C | N |
| 5 | Cardio | Blood-Pressure Cuff | 870.1120 | II | DXQ | 1 | N | N |
| 6 | Cardio | Angiography Catheter | 870.1200 | II | DQO | 3 | C | N |
| 7 | Cardio | Electrode Recording Catheter | 870.1220 | II | DRF | 3 | C | N |
| 8 | Cardio | High-Density Array Catheter | 870.1220 | II | MTD | 3 | C | N |
| 9 | Cardio | Fiberoptic Oximeter Catheter | 870.1230 | II | DQE | 3 | C | N |
| 10 | Cardio | Steerable Catheter | 870.1280 | II | DRA | 3 | C | N |
| 11 | Cardio | Steerable Catheter Control System | 870.1290 | II | DXX | 3 | C | N |
| 12 | Cardio | Guide Wire | 870.1330 | II | DQX | 3 | C | N |
| 13 | Cardio | Angiographic Needle | 870.1390 | II | DRC | 3 | C | N |
| 14 | Cardio | Trocar | 870.1390 | II | DRC | 3 | C | N |
| 15 | Cardio | Syringes | 870.1650 | II | DXT | 3 | C | N |
| 16 | Cardio | Injector Type Syringe Actuator | 870.1670 | II | DQF | 3 | C | N |
| 17 | Cardio | Oximeter | 870.2700 | II | DQA | 3 | N | N |
| 18 | Cardio | Tissue Saturation Oximeter | 870.2700 | II | MUD | 3 | C | N |
| 19 | Cardio | Intra-Aortic Balloon System | 870.3535 | III | DSP | 3 | C | N |
| 20 | Cardio | Vascular Clamp | 870.4450 | II | DXC | 3 | C | N |
| 21 | Cardio | Heart Stabilizer | 870.4500 | I | MWS | 2 | C | Y |
| 22 | Cardio | Noncompression Heart Stabilizer | 870.4500 | I | MWS | 3 | C | Y |
| 23 | Cardio | External Vein Stripper | 870.4885 | II | DWQ | 3 | C | N |
| 24 | Cardio | Compressible Limb Sleeve | 870.5800 | II | JOW | 1 | N | N |
| 25 | Dental | Bur | 872.3240 | I | EJL | 1 | C | Y |
| 26 | Dental | Diamond Coated Bur | 872.3240 | I | EJL | 3 | C | Y |
| 27 | Dental | Diamond Instrument | 872.4535 | I | DZP | 3 | C | Y |
| 28 | Dental | AC-Powered Bone Saw | 872.4120 | II | DZH | 2 | C | N |
| 29 | Dental | Manual Bone Drill and Wire Driver | 872.4120 | II | DZJ | 2 | C | N |
| 30 | Dental | Powered Bone Drill | 872.4120 | II | DZI | 2 | C | N |
| 31 | Dental | Intraoral Drill | 872.4130 | I | DZA | 1 | C | Y |
| 32 | Dental | Injection needle | 872.4730 | I | DZM | 3 | C | Y |
| 33 | Dental | Metal Orthodontic Bracket | 872.5410 | I | EJF | 3 | S | Y |
| 34 | Dental | Plastic Orthodontic Bracket | 872.5470 | II | DYW | 3 | S | N |
| 35 | ENT | Bur | 874.4140 | I | EQJ | 1 | C | Y |
| 36 | ENT | Diamond Coated Bur | 874.4140 | I | EQJ | 3 | C | Y |
| 37 | ENT | Microdebrider | 874.4140 | I | EQJ | 3 | C | Y |
| 38 | ENT | Microsurgical Argon Fiber Optic Laser Cable, For Uses Other Than Otology, Including Laryngology General Use In Otolaryngology | 874.4490 | II | LMS | 1 | S | N |
| 39 | ENT | Microsurgical Argon Fiber Optic Laser Cable, For Use In Otology | 874.4490 | II | LXR | 1 | S | N |
| 40 | ENT | Microsurgical Carbon-Dioxide Fiber Optic Laser Cable | 874.4500 | II | EWG | 1 | S | N |
| 41 | ENT | Bronchoscope Biopsy Forceps (Nonrigid) | 874.4680 | II | BWH | 3 | C | N |
| 42 | ENT | Bronchoscope Biopsy Forceps (Rigid) | 874.4680 | II | JEK | 1 | C | N |
| 43 | Gastro/ Urology | Biopsy Forceps Cover | 876.1075 | I | FFF | 1 | C | Y |
| 44 | Gastro/ Urology | Biopsy Instrument | 876.1075 | II | KNW | 3 | C | N |
| 45 | Gastro/ Urology | Biopsy Needle Set | 876.1075 | II | FCG | 3 | C | N |
| 46 | Gastro/ Urology | Biopsy Punch | 876.1075 | II | FCI | 2 | C | N |
| 47 | Gastro/ Urology | Mechanical Biopsy Instrument | 876.1075 | II | FCF | 2 | C | N |
| 48 | Gastro/ Urology | Nonelectric Biopsy Forceps | 876.1075 | I | FCL | 3 | C | Y |
| 49 | Gastro/ Urology | Cytology Brush For Endoscope | 876.1500 | II | FDX | 2 | S | N |
| 50 | Gastro/ Urology | Endoscope accessories | 876.1500 | II | KOG | 2 | S | N |
| 51 | Gastro/ Urology | Extraction Balloons/Baskets | 876.1500 | II | KOG | 2 | S | N |
| 52 | Gastro/Urology | Endoscopic needle | 876.1500 | II | FBK | 3 | C | N |
| 53 | Gastro/ Urology | Simple Pneumoperitoneum Needle | 876.1500 | II | FHP | 3 | C | N |
| 54 | Gastro/ Urology | Spring Loaded Pneumoperitoneum Needle | 876.1500 | II | FHO | 3 | C | N |
| 55 | Gastro/ Urology | Active Electrosurgical Electrode | 876.4300 | II | FAS | 3 | S | N |
| 56 | Gastro/ Urology | Biliary Sphincterotomes | 876.5010, 876.1500 | II | FGE | 3 | C | N |
| 57 | Gastro/ Urology | Electric Biopsy Forceps | 876.4300 | II | KGE | 3 | C | N |
| 58 | Gastro/ Urology | Electrosurgical Endoscopic Unit (With Or Without Accessories) | 876.4300 | II | KNS | 3 | S | N |
| 59 | Gastro/ Urology | Flexible Snare | 876.4300 | II | FDI | 3 | S | N |
| 60 | Gastro/ Urology | Flexible Suction Coagulator Electrode | 876.4300 | II | FEH | 3 | S | N |
| 61 | Gastro/ Urology | Flexible Stone Dislodger | 876.4680 | II | FGO | 3 | S | Y |
| 62 | Gastro/ Urology | Metal Stone Dislodger | 876.4680 | II | FFL | 3 | S | Y |
| 63 | Gastro/ Urology | Needle Holder | 876.4730 | I | FHQ | 1 | C | Y |
| 64 | Gastro/ Urology | Nonelectrical Snare | 876.4730 | I | FGX | 1 | S | Y |
| 65 | Gastro/ Urology | Urological Catheter | 876.5130 | II | KOD | 2 | S | N |
| 66 | Gastro/Urology | Single needle dialysis set | 876.5540 | II | LBW, FIE | 3 | C | N |
| 67 | Gastro/ Urology | Hemodialysis Blood Circuit Accessories | 876.5820 | II | KOC | 2 | S | N |
| 68 | Gastro/Urology | Single needle dialysis set | 876.5820 | II | FIF | 3 | C | N |
| 69 | Gastro/Urology | Hemorrhoidal Ligator | 876.4400 | II | FHN | 2 | C | N |
| 70 | General Hospital | Implanted, Programmable Infusion Pump | Post-amendment | III | LKK | 3 | C | N |
| 71 | General Hospital | Needle Destruction Device | Post-amendment | III | MTV | 1 | N | N |
| 72 | General Hospital | Nonpowered Flotation Therapy Mattress | 880.5150 | I | IKY | 2 | N | Y |
| 73 | General Hospital | NonAC-Powered Patient Lift | 880.5510 | I | FSA | 2 | N | Y |
| 74 | General Hospital | Alternating Pressure Air Flotation Mattress | 880.5550 | II | FNM | 1 | N | Y |
| 75 | General Hospital | Temperature Regulated Water Mattress | 880.5560 | I | FOH | 2 | N | Y |
| 76 | General Hospital | Hypodermic Single Lumen Needle | 880.5570 | II | FMI | 3 | C | N |
| 77 | General Hospital | Piston Syringe | 880.5860 | II | FMF | 3 | C | N |
| 78 | General Hospital | Mattress Cover (Medical Purposes) | 880.6190 | I | FMW | 2 | N | Y |
| 79 | General Hospital | Disposable Medical Scissors | 880.6820 | I | JOK | 1 | N | Y |
| 80 | General Hospital | Irrigating Syringe | 880.6960 | I | KYZ, KYY | 1 | C | Y |
| 81 | Infection Control | Surgical Gowns | 878.4040 | II | FYA | 1 | C | N |
| 82 | Lab | Blood Lancet | 878.4800 | I | FMK | 1 | C | Y |
| 83 | Neurology | Clip Forming/Cutting Instrument, | 882.4190 | I | HBS | 3* | C | Y |
| 84 | Neurology | Drills, Burrs, Trephines Accessories (Manual) | 882.4300 | II | HBG | 3* | C | N |
| 85 | Neurology | Drills, Burrs, Trephines Accessories (Compound, Powered) | 882.4305 | II | HBF | 3* | C | N |
| 86 | Neurology | Drills, Burrs, Trephines Accessories (Simple, Powered) | 882.4310 | II | HBE | 3* | C | N |
| 87 | OB/GYN | Oocyte aspiration needle | III | MHK | 3 | C | N | |
| 88 | OB/GYN | Laparoscope accessories | 884.1720 | I | HET | 2 | C | Y |
| 89 | OB/GYN | Laparoscope Accessories | 884.1720 | II | HET | 3 | C | N |
| 90 | OB/GYN | Laparoscopic Dissectors | 884.1720 | I | HET | 2 | C | Y |
| 91 | OB/GYN | Laparoscopic Graspers | 884.1720 | I | HET | 2 | C | Y |
| 92 | OB/GYN | Laparoscopic Scissors | 884.1720 | I | HET | 2 | C | Y |
| 93 | OB/GYN | Insufflator accessories (tubing, Verres needle, kits) | 884.1730 | II | HIF | 3 | C | Y |
| 94 | OB/GYN | Laparoscopic Insufflator | 884.1730 | II | HIF | 2 | N | N |
| 95 | OB/GYN | Endoscopic Electrocautery and Accessories | 884.4100 | II | HIM | 2 | N | N |
| 96 | OB/GYN | Gynecologic Electrocautery (and Accessories) | 884.4120 | II | HGI | 2 | N | N |
| 97 | OB/GYN | Endoscopic Bipolar Coagulator-Cutter (and Accessories) | 884.4150 | II | HIN | 2 | N | N |
| 98 | OB/GYN | Culdoscopic Coagulator (and Accessories) | 884.4160 | II | HFI | 2 | N | N |
| 99 | OB/GYN | Endoscopic Unipolar Coagulator-Cutter (and Accessories) | 884.4160 | II | KNF | 2 | N | N |
| 100 | OB/GYN | Hysteroscopic Coagulator (and Accessories) | 884.4160 | II | HFH | 2 | N | N |
| 101 | OB/GYN | Unipolar Laparoscopic Coagulator (and Accessories) | 884.4160 | II | HFG | 2 | N | N |
| 102 | OB/GYN | Episiotomy Scissors | 884.4520 | I | HDK | 1 | C | Y |
| 103 | OB/GYN | Umbilical Scissors | 884.4520 | I | HDJ | 1 | C | Y |
| 104 | OB/GYN | Biopsy Forceps | 884.4530 | I | HFB | 3 | C | Y |
| 105 | OB/GYN | Assisted reproduction needle | 884.6100 | II | MQE | 3 | C | N |
| 106 | Ophthalmic | Endoilluminator | 876.1500 | II | MPA | 3* | C | N |
| 107 | Ophthalmic | Surgical Drapes | 878.4370 | II | KKX | 2 | C | N |
| 108 | Ophthalmic | Ophthalmic Knife | 886.4350 | I | HNN | 3 | C | Y |
| 109 | Ophthalmic | Keratome Blade | 886.4370 | I | HMY, HNO | 3 | C | N |
| 110 | Ophthalmic | Phacoemulsification Needle | 886.4670 | II | HQC | 3 | C | N |
| 111 | Ophthalmic | Phacoemulsification/ Phacofragmentation Fluidic | 886.4670 | II | MUS | 2 | C | N |
| 112 | Ophthalmic | Phacofragmentation Unit | 886.4670 | II | HQC | 1 | N | N |
| 113 | Orthopedic | Saw Blades | 878.4820 | I | GFA, DWH, GEY, GET | 1 | C | Y |
| 114 | Orthopedic | Surgical Drills | 878.4820 | I | GEY, GET | 1 | C | Y |
| 115 | Orthopedic | Arthroscope accessories | 888.1100 | II | HRX | 2 | C | Y |
| 116 | Orthopedic | Bone Tap | 888.4540 | I | HWX | 1 | C | Y |
| 117 | Orthopedic | Burr | 888.4540 | I | HTT | 1 | C | Y |
| 118 | Orthopedic | Carpal Tunnel Blade | 888.4540 | I | LXH | 2 | C | Y |
| 119 | Orthopedic | Countersink | 888.4540 | I | HWW | 1 | C | Y |
| 120 | Orthopedic | Drill Bit | 888.4540 | I | HTW | 1 | C | Y |
| 121 | Orthopedic | Knife | 888.4540 | I | HTS | 1 | C | Y |
| 122 | Orthopedic | Manual Surgical Instrument | 888.4540 | I | LXH | 1 | C | Y |
| 123 | Orthopedic | Needle Holder | 888.4540 | I | HXK | 1 | C | Y |
| 124 | Orthopedic | Reamer | 888.4540 | I | HTO | 1 | C | Y |
| 125 | Orthopedic | Rongeur | 888.4540 | I | HTX | 1 | C | Y |
| 126 | Orthopedic | Scissors | 888.4540 | I | HRR | 1 | C | Y |
| 127 | Orthopedic | Staple Driver | 888.4540 | I | HXJ | 1 | C | Y |
| 128 | Orthopedic | Trephine | 888.4540 | I | HWK | 1 | C | Y |
| 129 | Orthopedic | Flexible Reamers/Drills | 886.4070 878.4820 | I | GEY, HRG | 1 | C | Y |
| 130 | Orthopedic | External Fixation Frame | 888.3040 888.3030 | II | JEC KTW KTT | 2 | N | N |
| 131 | Physical Medicine | Nonheating Lamp for Adjunctive Use Inpatient Therapy | 890.5500 | II | NHN | 1 | N | N |
| 132 | Physical Medicine | Electrode Cable, | 890.1175 | II | IKD | 1 | N | Y |
| 133 | Physical Medicine | External Limb Component, Hip Joint | 890.3420 | I | ISL | 2 | N | Y |
| 134 | Physical Medicine | External Limb Component, Knee Joint | 890.3420 | I | ISY | 2 | N | Y |
| 135 | Physical Medicine | External Limb Component, Mechanical Wrist | 890.3420 | I | ISZ | 2 | N | Y |
| 136 | Physical Medicine | External Limb Component, Shoulder Joint | 890.3420 | I | IQQ | 2 | N | Y |
| 137 | Plastic Surgery | Stapler | 878.4800 | I | GAG, GEF, FHM, HBT | 2 | C | Y |
| 138 | Radiology | Isotope Needle | 892.5730 | II | IWF | 3 | C | N |
| 139 | Respiratory | Endotracheal Tube Changer | Unclassified | III | LNZ | 3 | C | N |
| 140 | Respiratory | Anesthesia conduction needle | 868.5150 | II | BSP | 3 | C | N |
| 141 | Respiratory | Short term spinal needle | 868.5150 | II | MIA | 3 | C | N |
| 142 | Respiratory | Respiratory Therapy and Anesthesia Breathing Circuits | 868.5240 | I | CAI | 2 | S | Y |
| 143 | Respiratory | Oral and Nasal Catheters | 868.5350 | I | BZB | 1 | C | Y |
| 144 | Respiratory | Gas Masks | 868.5550 | I | BSJ | 1 | S | Y |
| 145 | Respiratory | Breathing Mouthpiece | 868.5620 | I | BYP | 1 | N | Y |
| 146 | Respiratory | Tracheal Tube | 868.5730 | II | BTR | 3 | C | N |
| 147 | Respiratory | Airway Connector | 868.5810 | I | BZA | 2 | S | Y |
| 148 | Respiratory | CPAP Mask | 868.5905 | II | BZD | 3 | S | N |
| 149 | Respiratory | Emergency Manual Resuscitator | 868.5915 | II | BTM | 2 | S | N |
| 150 | Respiratory | Tracheobronchial Suction Catheter | 868.6810 | I | BSY | 3 | S | Y |
| 151 | Surgery | AC-powered Orthopedic Instrument and accessories | 878.4820 | I | HWE | 2 | C | N |
| 152 | Surgery | Breast Implant Mammary Sizer | Unclassified | MRD | 1 | C | N | |
| 153 | Surgery | Ultrasonic Surgical Instrument | Unclassified | LFL | 3 | C | N | |
| 154 | Surgery | Trocar | 874.4420 | I | KAB, KBG, KCI | 3 | C | Y |
| 155 | Surgery | Endoscopic Blades | 876.1500 | II | GCP, GCR | 2 | C | N |
| 156 | Surgery | Endoscopic Guidewires | 876.1500 | II | GCP, GCR | 1 | C | N |
| 157 | Surgery | Inflatable External Extremity Splint | 878.3900 | I | FZF | 1 | N | Y |
| 158 | Surgery | Noninflatable External Extremity Splint | 878.3910 | I | FYH | 1 | N | Y |
| 159 | Surgery | Catheter needle | 878.4200 | I | GCB | 3 | C | Y |
| 160 | Surgery | Implantable Clip | 878.4300 | II | FZP | 3 | C | N |
| 161 | Surgery | Electrosurgical and Coagulation Unit With Accessories | 878.4400 | II | BWA | 2 | C | N |
| 162 | Surgery | Electrosurgical Apparatus | 878.4400 | II | HAM | 2 | C | N |
| 163 | Surgery | Electrosurgical Cutting Coagulation Device Accessories | 878.4400 | II | GEI NUJ | 2 3 | C | N |
| 164 | Surgery | Electrosurgical Device | 878.4400 | II | DWG | 2 | C | N |
| 165 | Surgery | Electrosurgical Electrode | 878.4400 | II | JOS | 2 | C | N |
| 166 | Surgery | Implantable Staple, Clamp, Clip for Suturing Apparatus | 878.4750 | II | GDW | 3 | C | N |
| 167 | Surgery | Percutaneous biopsy device | 878.4800 | I | MJG | 3 | C | Y |
| 168 | Surgery | Gastro-Urology needle | 878.4800 | I | FHR | 3 | C | Y |
| 169 | Surgery | Aspiration and injection needle | 878.4800 | I | GAA | 3 | C | Y |
| 170 | Surgery | Biopsy Brush | 878.4800 | I | GEE | 1 | C | Y |
| 171 | Surgery | Blood Lancet | 878.4800 | I | FMK | 1 | C | Y |
| 172 | Surgery | Bone Hook | 878.4800 | I | KIK | 1 | C | Y |
| 173 | Surgery | Cardiovascular Biopsy Needle | 878.4800 | I | DWO | 3 | C | Y |
| 174 | Surgery | Clamp | 878.4800 | I | GDJ | 1 | C | Y |
| 175 | Surgery | Clamp | 878.4800 | I | HXD | 1 | C | Y |
| 176 | Surgery | Curette | 878.4800 | I | HTF | 1 | C | Y |
| 177 | Surgery | Disposable Surgical Instrument | 878.4800 | I | KDC | 1 | C | Y |
| 178 | Surgery | Disposable Vein Stripper | 878.4800 | I | GAJ | 1 | C | Y |
| 179 | Surgery | Dissector | 878.4800 | I | GDI | 1 | C | Y |
| 180 | Surgery | Forceps | 878.4800 | I | GEN | 2 | C | Y |
| 181 | Surgery | Forceps | 878.4800 | I | HTD | 2 | C | Y |
| 182 | Surgery | Gouge | 878.4800 | I | GDH | 1 | C | Y |
| 183 | Surgery | Hemostatic Clip Applier | 878.4800 | I | HBT | 2 | C | Y |
| 184 | Surgery | Hook | 878.4800 | I | GDG | 1 | C | Y |
| 185 | Surgery | Manual Instrument | 878.4800 | I | MDM, MDW | 1 | C | Y |
| 186 | Surgery | Manual Retractor | 878.4800 | I | GZW | 1 | C | Y |
| 187 | Surgery | Manual Saw and Accessories | 878.4800 | I | GDR HAC | 1 | C | Y |
| 188 | Surgery | Manual Saw and Accessories | 878.4800 | I | HAC | 1 | C | Y |
| 189 | Surgery | Manual Surgical Chisel | 878.4800 | I | FZO | 1 | C | Y |
| 190 | Surgery | Mastoid Chisel | 878.4800 | I | JYD | 1 | C | Y |
| 191 | Surgery | Orthopedic Cutting Instrument | 878.4800 | I | HTZ | 1 | C | Y |
| 192 | Surgery | Orthopedic Spatula | 878.4800 | I | HXR | 1 | C | Y |
| 193 | Surgery | Osteotome | 878.4800 | I | HWM | 1 | C | Y |
| 194 | Surgery | Rasp | 878.4800 | I | GAC | 1 | C | Y |
| 195 | Surgery | Rasp | 878.4800 | I | HTR | 1 | C | Y |
| 196 | Surgery | Retractor | 878.4800 | I | GAD | 1 | C | Y |
| 197 | Surgery | Retractor | 878.4800 | I | HXM | 1 | C | Y |
| 198 | Surgery | Saw | 878.4800 | I | HSO | 1 | C | Y |
| 199 | Surgery | Scalpel Blade | 878.4800 | I | GES | 1 | C | Y |
| 200 | Surgery | Scalpel Handle | 878.4800 | I | GDZ | 1 | C | Y |
| 201 | Surgery | Scissors | 878.4800 | I | LRW | 1 | C | Y |
| 202 | Surgery | Snare | 878.4800 | I | GAE | 1 | C | Y |
| 203 | Surgery | Spatula | 878.4800 | I | GAF | 1 | C | Y |
| 204 | Surgery | Staple Applier | 878.4800 | I | GEF | 2 | C | Y |
| 205 | Surgery | Stapler | 878.4800 | I | GAG | 2 | C | Y |
| 206 | Surgery | Stomach and Intestinal Suturing Apparatus | 878.4800 | I | FHM | 2 | C | Y |
| 207 | Surgery | Surgical Curette | 878.4800 | I | FZS | 1 | C | Y |
| 208 | Surgery | Surgical Cutter | 878.4800 | I | FZT | 1 | C | Y |
| 209 | Surgery | Surgical Knife | 878.4800 | I | EMF | 1 | S | Y |
| 210 | Surgery | Laser Powered Instrument | 878.4810 | II | GEX | 2 | C | N |
| 211 | Surgery | AC-Powered Motor | 878.4820 | I | GEY | 2 | C | Y |
| 212 | Surgery | Bit | 878.4820 | I | GFG | 1 | C | Y |
| 213 | Surgery | Bur | 878.4820 | I | GFF, GEY | 1 | C | Y |
| 214 | Surgery | Cardiovascular Surgical Saw Blade | 878.4820 | I | DWH | 1 | C | Y |
| 215 | Surgery | Chisel (Osteotome) | 878.4820 | I | KDG | 1 | C | Y |
| 216 | Surgery | Dermatome | 878.4820 | I | GFD | 1 | C | Y |
| 217 | Surgery | Electrically Powered Saw | 878.4820 | I | DWI | 2 | C | Y |
| 218 | Surgery | Pneumatic Powered Motor | 878.4820 | I | GET | 2 | C | Y |
| 219 | Surgery | Pneumatically Powered Saw | 878.4820 | I | KFK | 2 | C | Y |
| 220 | Surgery | Powered Saw and Accessories | 878.4820 | I | HAB | 2 | C | Y |
| 221 | Surgery | Saw Blade | 878.4820 | I | GFA | 1 | C | Y |
| 222 | Surgery | Nonpneumatic Tourniquet | 878.5900 | I | GAX | 1 | N | Y |
| 223 | Surgery | Pneumatic Tourniquet | 878.5910 | I | KCY | 1 | N | Y |
| 224 | Surgery | Endoscopic Staplers | 888.4540 | I | HXJ | 2 | C | Y |
| 225 | Surgery | Trocar | 876.1500 870.1390 | II | GCJ, DRC | 3 | C | N |
| 226 | Surgery | Surgical Cutting Accessories | 878.4800, 874.4420 | I | GDZ, GDX, GES, KBQ, KAS | 2 | C | Y |
| 227 | Surgery | Electrosurgical Electrodes/Handles/Pencils | 876.4300 878.4400 | II | HAM, GEI, FAS | 2 | C | N |
| 228 | Surgery | Scissor Tips | 878.4800, 884.4520, 874.4420 | I | LRW, HDK, HDJ, JZB, KBD | 2 | C | Y |
| 229 | Surgery | Laser Fiber Delivery Systems | 878.4810 874.4500 886.4390 884.4550 886.4690 | II | GEX EWG LLW HQF HHR HQB | 1 | C | N |
| A Risk categorization may be either: | ||||||||
| 1 = low risk according to RPS | ||||||||
| 2 = moderate risk according to RPS | ||||||||
| 3 = high risk according to RPS | ||||||||
| 3* = high risk due to neurological use | ||||||||
| See section II of this document, "FDA's Implementation of New Section 510(o) of the Act" for methodology and criteria used to identify the risk. | ||||||||
Dated: September 22, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-19510 Filed 9-28-05; 8:45 am]
BILLING CODE 4160-01-S