KFK
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Saw, Pneumatically Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1997: 2 · 1999: 2 · 2005: 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 |
|---|---|---|
| #157 EXAM LIGHT (K893949) | Medmark, Inc. | 1989-08-07 |
| MICRO-AIRE STERNUM SAW 4800 (K894301) | Micro Surgical Instruments Corp. | 1989-08-03 |
| OSCILLATING SAW/ RECIPROCATING SAW/ DRILL-REAMER (K870157) | Micro-Aire Surgical Instruments, Inc. | 1987-02-24 |
| STERNUM SAW (K801737) | Amsco Co. | 1980-08-20 |
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Every clearance here is in the API, with alerts when new ones post.