Forceps, Ent
FDA product code KAE · Class I (low risk) · 21 CFR 874.4420 · Ear, Nose, Throat
14510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K853708 | Laryngascopes, Forceps, Micro Suction Tube & RefleKAE · Traditional | Downs Surgical , Ltd. | 02/14/1986SE |
| K851795 | 41-250 to 41-282 Various Nasal Cutting ForcepsKAE · Traditional | Artiberia | 06/11/1985SE |
| K851794 | 41-180 to 41-246 Various Nasal ForcepsKAE · Traditional | Artiberia | 06/11/1985SE |
| K851775 | 19-790 to 19-1042 Dressing/Sponge ForcepsKAE · Traditional | Artiberia | 06/11/1985SE |
| K833608 | Gold Alligator ForcepsKAE · Traditional | Microtek Medical, Inc. | 01/11/1984SE |
| K833607 | Mcgee ForcepsKAE · Traditional | Microtek Medical, Inc. | 01/03/1984SE |
| K833605 | Cupped ForcepsKAE · Traditional | Microtek Medical, Inc. | 01/03/1984SE |
| K822372 | Office Econo-ForcepsKAE · Traditional | Treace Medical, Inc. | 09/09/1982SE |
| K822369 | Micro & Mini-Micro Alligator ForcepsKAE · Traditional | Treace Medical, Inc. | 09/09/1982SE |
| K812895 | Yarmo Nasal Cartilage SoftenerKAE · Traditional | American V. Mueller | 11/02/1981SE |
| K772398 | Cottle Lower Lateral ForcepsKAE · Traditional | Edward Weck, Inc. | 01/17/1978SE |
| K772397 | Cottle Columella ForcepKAE · Traditional | Edward Weck, Inc. | 01/17/1978SE |
| K772396 | Alligator Cup ForcepsKAE · Traditional | Edward Weck, Inc. | 01/17/1978SE |
| K772377 | Hildyard Post Nasal ForcepKAE · Traditional | Edward Weck, Inc. | 01/17/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1312-2025 Class II | Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps…The forceps have been used in ways not covered by the design resulting in breakage of the clamps. | Aesculap Inc | 01/31/2025Open, Classified |