FFE
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- System, Water Jet Catheter, Renal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4650
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 1992: 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 |
|---|---|---|
| OLYMPUS CD-6C-1 COAGULATION ELECTRODE (K971328) | Olympus America, Inc. | 1997-07-01 |
Track FFE automatically
Every clearance here is in the API, with alerts when new ones post.