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Medical Devices

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 NameProduct Code for Nonreprocessed DeviceProduct Code for Reprocessed DeviceProduct Code Name for Reprocessed Device
868.6810Tracheobronchial Suction CatheterBSYNQVTracheobronchial Suction Catheter
870.4500Cardiovascular Surgical InstrumentsMWSNQGNoncompression Heart Stabilizer
872.3240Dental BurDiamond CoatedNMEDental Diamond Coated Bur
872.4535Dental Diamond InstrumentDZPNLDDental Diamond Instrument
872.4730Dental Injection NeedleDZMNMWDental Needle
872.5410Orthodontic Appliance and AccessoriesEJFNQSOrthodontic Metal Bracket
874.4140Ear, Nose, and Throat BurMicrodebriderNLYENT High Speed Microdebrider
874.4140Ear, Nose, and Throat BurDiamond CoatedNLZENT Diamond Coated Bur
874.4420Ear, Nose, Throat Manual SurgicalKAB, KBG, KCINLBLaryngeal, Sinus, Tracheal Trocar
876.1075Gastroenterology- Urology Biopsy InstrumentFCLNONNonelectric Biopsy Forceps
876.4680Ureteral Stone DislodgerFGO, FFLNQT, NQUFlexible and Basket Stone Dislodger
878.4200Introduction/Drainage Catheter and AccessoriesGCBNMTCatheter Needle
878.4800Manual Surgical InstrumentMJGNNAPercutaneous Biopsy Device
878.4800Manual Surgical InstrumentFHRNMUGastro-Urology Needle
878.4800Manual Surgical Instrument for . . .DWONLKCardiovascular Biopsy Needle
878.4800Manual Surgical Instrument for . . .GAANNCAspiration and Injection Needle
882.4190Forming/Cutting Clip InstrumentHBSNMNForming/Cutting Clip Instrument
884.1730Laparoscopic Insufflator, . . .HIFNMILaparoscopic Insufflator and Accessories
884.4530OB/GYN Specialized Manual InsrumentHFBNMGGynecological Biopsy Forceps
886.4350Manual Ophthalmic Surgical InstrumentHNNNLAOphthalmic Knife

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