GEF
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Applier, Staple, Surgical,
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2021: 20 · 2022: 18 · 2023: 18 · 2024: 44 · 2025: 55 · 2026: 51
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 |
|---|---|---|
| REFLEX SDD SURGICAL STAPLER (K933508) | Richard-Allan Medical | 1993-11-23 |
| MICROAIRE MODEL 2600 (K915670) | Microaire | 1992-03-18 |
| V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP (K854568) | American V. Mueller | 1985-12-02 |
| 3M FRASCIA STAPLING SYSTEM (K823888) | 3M Company | 1983-01-09 |
Track GEF automatically
Every clearance here is in the API, with alerts when new ones post.