Bur, Ear, Nose And Throat
FDA product code EQJ · Class I (low risk) · 21 CFR 874.4140 · Ear, Nose, Throat
18510(k) clearances
0PMA approvals
3recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K161514 | Precision Thin Reciprocating Blade, 0.010in.EQJ · Traditional | Stryker Corporation | 01/17/2017SE |
| K041985 | XPS Curved BurEQJ · Traditional | Medtronic Xomed, Inc. | 08/12/2004SE |
| K974232 | Essential Shaver SystemEQJ · Traditional | Gyrus Ent LLC | 01/12/1998SE |
| K960853 | Ace SystemEQJ · Traditional | Xomed, Inc. | 04/03/1996SE |
| K955704 | Trebay Microdebrider SystemEQJ · Traditional | Trebay Medical Corp. | 01/30/1996SE |
| K955294 | Sof - Abrasion BurEQJ · Traditional | Trebay Medical Corp. | 12/22/1995SE |
| K954912 | Trebay Irrigated Cutter Blade (Modification)EQJ · Traditional | Trebay Medical Corp. | 12/06/1995SE |
| K953370 | Karl Storz ENT ShaverEQJ · Traditional | KARL STORZ Endoscopy-America, Inc. | 09/06/1995SE |
| K950337 | Karl Storz Stammberger-Sachse Intranasal-FrillEQJ · Traditional | KARL STORZ Endoscopy-America, Inc. | 08/23/1995SE |
| K952609 | Redi Drill Drill SystemEQJ · Traditional | Trebay Medical Corp. | 07/31/1995SE |
| K953096 | Essential Shaver SystemEQJ · Traditional | Smith & Nephew Richards, Inc. | 07/28/1995SE |
| K946332 | Karl Storz Micro-Instrument for Cochlear ImplantationEQJ · Traditional | KARL STORZ Endoscopy-America, Inc. | 06/05/1995SE |
| K951526 | Trebay Irrgated Cutter BladeEQJ · Traditional | Trebay Medical Corp. | 05/12/1995SE |
| K935584 | Mednext BurEQJ · Traditional | Mednext, Inc. | 02/22/1994SE |
| K895738 | Micromedics Ear, Nose and Throat BursEQJ · Traditional | Micromedics, Inc. | 12/19/1989SE |
| K893499 | CMS Fast Cut, CMS Diamond and CMS Wire PassEQJ · Traditional | Cmsi | 11/16/1989SE |
| K802503 | Micro-Sugical Power Instrument SystemEQJ · Traditional | Spire Medical, Inc. | 10/31/1980SE |
| K792028 | Ototome BurEQJ · Traditional | American Sterilizer Co. | 10/26/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3130-2024 Class II | Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069Product was distributed past expiration date. | Medtronic Xomed, Inc. | 07/05/2024Open, Classified |
| Z-0156-2022 Class II | Medtronic sterile single-use blades that are components of the StraightShot M Series…There was an increase in complaints related to tip breaks and wobble/vibration. | Medtronic Xomed, Inc. | 08/31/2021Open, Classified |
| Z-1337-2018 Class II | Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system"Chattering" when cutting burrs are used in bone. | Gyrus ACMI, Inc. | 08/03/2017Open, Classified |