FGH
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Catheter, Double Lumen Female Urethrographic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Medical specialty
- Gastroenterology, Urology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1992: 8 · 1993: 1 · 1994: 6 · 1995: 3 · 2015: 19
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 |
|---|---|---|
| BARD HYDROGEL-COATED DIAGNOSTIC URETHRAL CATHETERS (K910196) | C.R. Bard, Inc. | 1991-03-27 |
Track FGH automatically
Every clearance here is in the API, with alerts when new ones post.