KAE
14 FDA 510(k) clearances · Product code
47 daysmedian time to decision
91 days90th percentile
14clearances measured
FDA profile
- Official device name
- Forceps, Ent
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Medical specialty
- Ear, Nose, Throat
- Adverse events (MAUDE)
- 1998: 5 · 1999: 1 · 2000: 2 · 2001: 1 · 2013: 23 · 2015: 8
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| LARYNGASCOPES, FORCEPS, MICRO SUCTION TUBE & REFLE (K853708) | Downs Surgical , Ltd. | 1986-02-14 |
| 41-250 TO 41-282 VARIOUS NASAL CUTTING FORCEPS (K851795) | Artiberia | 1985-06-11 |
| 19-790 TO 19-1042 DRESSING/SPONGE FORCEPS (K851775) | Artiberia | 1985-06-11 |
| 41-180 TO 41-246 VARIOUS NASAL FORCEPS (K851794) | Artiberia | 1985-06-11 |
| GOLD ALLIGATOR FORCEPS (K833608) | Microtek Medical, Inc. | 1984-01-11 |
| MCGEE FORCEPS (K833607) | Microtek Medical, Inc. | 1984-01-03 |
| CUPPED FORCEPS (K833605) | Microtek Medical, Inc. | 1984-01-03 |
| MICRO & MINI-MICRO ALLIGATOR FORCEPS (K822369) | Treace Medical, Inc. | 1982-09-09 |
| OFFICE ECONO-FORCEPS (K822372) | Treace Medical, Inc. | 1982-09-09 |
| YARMO NASAL CARTILAGE SOFTENER (K812895) | American V. Mueller | 1981-11-02 |
| HILDYARD POST NASAL FORCEP (K772377) | Edward Weck, Inc. | 1978-01-17 |
| COTTLE COLUMELLA FORCEP (K772397) | Edward Weck, Inc. | 1978-01-17 |
| ALLIGATOR CUP FORCEPS (K772396) | Edward Weck, Inc. | 1978-01-17 |
| COTTLE LOWER LATERAL FORCEPS (K772398) | Edward Weck, Inc. | 1978-01-17 |
Track KAE automatically
Every clearance here is in the API, with alerts when new ones post.