GFI
6 FDA 510(k) clearances · Product code
83 daysmedian time to decision
267 days90th percentile
6clearances measured
FDA profile
- Official device name
- Osteotome, Manual
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1998: 2 · 2000: 2 · 2002: 9 · 2003: 1 · 2009: 3 · 2015: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| VALLEYLAB FORCE GSU HANDSET ADAPTER MODEL #E0500 (K933181) | Valleylab, Inc. | 1993-11-02 | + Add |
| ISI FENESTRATED DISSECTING AND GRASPING FORCEPS (K932534) | Innovative Surgical, Inc. | 1993-08-19 | + Add |
| HEMOLAB SILIMAT REAGENT (K920001) | Biomerieux Vitek, Inc. | 1992-09-25 | + Add |
| OSTEOTOMES, VARIOUS TYPES (K891887) | Zinnanti Surgical Instruments, Inc. | 1989-04-12 | + Add |
| STORZ ION BOND OSTEOTOMES & RASPS, FAST CU BURS (K852541) | Storz Instrument Co. | 1985-07-11 | + Add |
| CHERMEL OSTEOTOMES (K842823) | Cher Mel Corp. | 1984-08-02 | + Add |
Track GFI automatically
Every clearance here is in the API, with alerts when new ones post.