FES
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Recorder, External, Pressure, Amplifier & Transducer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1725
- Medical specialty
- Gastroenterology, Urology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1992: 1 · 1998: 1
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 |
|---|---|---|
| URODEC 500 (K890284) | Ferguson Medical | 1989-05-30 |
| MMI/GAELTEC CATHETER TIP PRESS. TRANSDU (K801757) | Medical Measurements, Inc. | 1980-08-27 |
Track FES automatically
Every clearance here is in the API, with alerts when new ones post.