GFG
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Bit, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2021: 68 · 2022: 69 · 2023: 52 · 2024: 79 · 2025: 110 · 2026: 80
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| MITEK MODULAR DRILL BIT (K935225) | Mitek Surgical Products, Inc. | 1994-04-07 | + Add |
| MICRO DRILLS (K821486) | Spire Medical, Inc. | 1982-06-09 | + Add |
| KEY DRILL (K821127) | Key Medical, Inc. | 1982-06-03 | + Add |
Track GFG automatically
Every clearance here is in the API, with alerts when new ones post.