GAC
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Rasp, Surgical, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2002: 5 · 2003: 2
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 |
|---|---|---|
| RUBIN BONE PLANER W/REPLACEABLE BLADE (K884473) | Neo Contemporary Co. | 1988-12-09 |
| MORGAN ARTHROSCOPIC MENESUS & SYNOVIAL RASP (K853601) | Bowen & Company, Inc. | 1985-09-16 |
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Every clearance here is in the API, with alerts when new ones post.