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U.S. Department of Health and Human Services

Medical Devices

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List 1 – Critical and Semicritical Reprocessed Single-Use Devices Previously Exempt From Premarket Notification Requirements that Now Require 510(k)s With Validation Data

From September 29, 2005, Federal Register Notice)

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 Insrument HFB NMG Gynecological Biopsy Forceps
886.4350 Manual Ophthalmic Surgical Instrument HNN NLA Ophthalmic Knife