GFF
16 FDA 510(k) clearances · Product code
21 daysmedian time to decision
125 days90th percentile
16clearances measured
FDA profile
- Official device name
- Bur, Surgical, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2021: 76 · 2022: 68 · 2023: 96 · 2024: 124 · 2025: 72 · 2026: 69
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 |
|---|---|---|
| ANSPACH SHIELDED ATTACHMENT (K974025) | The Anspach Effort, Inc. | 1998-07-06 |
| SURGICAL BUR (K950449) | Transidyne General Corp. | 1995-03-01 |
| SURGICAL BUR (K943758) | Komet Medical | 1994-08-22 |
| BURRS (K934583) | American Medical Specialties, Inc. | 1994-01-26 |
| MICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTS (K894438) | Micro-Aire Surgical Instruments, Inc. | 1989-08-21 |
| DANEK IRRIGATING BURR (DIB) SET (K890090) | Danek Medical, Inc. | 1989-01-24 |
| KOMET SURGICAL BUR (K883255) | Komet Medical, Div. of Brasseler USA I, L.P. | 1988-09-15 |
| SURGICAL BURS (K880859) | New England Surgical Instrument Corp. | 1988-03-21 |
| SURGICAL BURS (K880706) | Nuell Air Equipment & Hospital Supplies, Inc. | 1988-02-26 |
| SURGICAL BUR (K872475) | Tava Surgical Instruments | 1987-07-02 |
| MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR (K862852) | Micro-Aire Surgical Instruments, Inc. | 1986-08-11 |
| BURS FOR MICRO SURGICAL DRILL SYSTEM (K853658) | Acumed Instruments Corp. | 1985-09-24 |
| MICRO-AIRE GENERIC BURS & DRILLS (K850497) | Micro-Aire Surgical Instruments, Inc. | 1985-03-01 |
| HOLE CHAMFERING DEVICE (K841298) | Techmedica, Inc. | 1984-04-25 |
| DERMABRADERS (K821485) | Spire Medical, Inc. | 1982-06-10 |
| MICRO-AIRE REPLACEMENT DRILL BURS (K820281) | Micro-Aire Surgical Instruments, Inc. | 1982-02-23 |
Track GFF automatically
Every clearance here is in the API, with alerts when new ones post.