GFJ
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Mallet, Surgical, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2003: 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 |
|---|---|---|
| 29-200 TO 29-230 VARIOUS BONE MALLETS(WIHIGER, DOY (K851789) | Artiberia | 1985-06-20 |
| MICROTENS 7757 T.E.N.S. STIMULATOR (K844017) | Rabar, Inc. | 1984-11-30 |
| ENT MALLETS (K822204) | Kelleher Corp. | 1982-09-17 |
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Every clearance here is in the API, with alerts when new ones post.