FGI
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Catheter, Urethrographic, Male
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Medical specialty
- Gastroenterology, Urology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1993: 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 |
|---|---|---|
| VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000 (K023019) | Vomed Volzer Medizintechnik GmbH & Co. | 2002-12-10 |
| DFINER UROLOGICAL CATHETER (K013360) | Neoseed Technology,Llc | 2002-02-20 |
| POLLACK CHAIN CYSOURETHROGRAM SET (K810370) | Vance Products, Inc. | 1981-03-20 |
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Every clearance here is in the API, with alerts when new ones post.