FGK
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Tripsor, Stone, Bladder
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4500
- Medical specialty
- Gastroenterology, Urology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1993: 1 · 1994: 1 · 1996: 2 · 1997: 3
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 |
|---|---|---|
| LITHOTRITE (K760273) | V. Mueller O.V. Baxter Healthcare Corp. | 1976-12-06 |
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Every clearance here is in the API, with alerts when new ones post.