FEH
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Electrode, Flexible Suction Coagulator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4300
- Medical specialty
- Gastroenterology, Urology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1992: 1 · 1994: 3 · 1995: 2 · 1997: 2 · 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 |
|---|---|---|
| ELECTRODE, FLEXIBLE SUCTION COAGULATOR (K130489) | Optim, LLC | 2013-04-19 |
| PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 (K122593) | Optim, LLC | 2012-09-13 |
| ACMI BIPOLAR HEMOSTATIC ELECTRODE (K803214) | American Cystocope Makers, Inc. | 1981-01-15 |
Track FEH automatically
Every clearance here is in the API, with alerts when new ones post.