FEC
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Obturator, For Endoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 1998: 13 · 1999: 2 · 2001: 2 · 2002: 3 · 2004: 1 · 2007: 2
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 |
|---|---|---|
| INTRODUCER SHEATH (K001328) | Novasys Medical, Inc. | 2000-07-17 |
| OBTURATOR, DEFLECTING (K760183) | V. Mueller O.V. Baxter Healthcare Corp. | 1976-12-02 |
| OBTURATOR, VISUAL (K760172) | V. Mueller O.V. Baxter Healthcare Corp. | 1976-12-02 |
Track FEC automatically
Every clearance here is in the API, with alerts when new ones post.