KCP
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Syringe, Ent
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.5220
- Medical specialty
- Ear, Nose, Throat
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1994: 2 · 1995: 1 · 1998: 1 · 1999: 2 · 2000: 4
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 |
|---|---|---|
| CAT. 7-EAR, NOSE & THROAT DEVICES (K840311) | Imm Enterprises , Ltd. | 1984-05-09 |
| EAR/ULCER SYRINGE (K822754) | American Hospital Supply Corp. | 1982-10-04 |
| AUTOMATIC TEFLON INJECTION SYRINGE (K810284) | R. Wolf Medical Instruments Corp. | 1981-03-11 |
| SYRINGE, EAR & ULCER (K780599) | Abco Dealers, Inc. | 1978-04-19 |
Track KCP automatically
Every clearance here is in the API, with alerts when new ones post.