GFF — Bur, Surgical, General & Plastic Surgery Class I
FDA product code GFF covers "Bur, Surgical, General & Plastic Surgery", a Class I medical device regulated under 21 CFR 878.4820. Submissions are reviewed by the General, Plastic Surgery panel. At least 16 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GFF
- Device Class
- Class I
- Regulation Number
- 878.4820
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K974025 | anspach effort | ANSPACH SHIELDED ATTACHMENT | July 6, 1998 |
| K950449 | transidyne general | SURGICAL BUR | March 1, 1995 |
| K943758 | komet medical | SURGICAL BUR | August 22, 1994 |
| K934583 | american medical specialties | BURRS | January 26, 1994 |
| K894438 | micro-aire surgical instruments | MICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTS | August 21, 1989 |
| K890090 | danek medical | DANEK IRRIGATING BURR (DIB) SET | January 24, 1989 |
| K883255 | komet medical, div. of brasseler usa i, l.p | KOMET SURGICAL BUR | September 15, 1988 |
| K880859 | new england surgical instrument | SURGICAL BURS | March 21, 1988 |
| K880706 | nuell air equipment and hospital supplies | SURGICAL BURS | February 26, 1988 |
| K872475 | tava surgical instruments | SURGICAL BUR | July 2, 1987 |
| K862852 | micro-aire surgical instruments | MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR | August 11, 1986 |
| K853658 | acumed instruments | BURS FOR MICRO SURGICAL DRILL SYSTEM | September 24, 1985 |
| K850497 | micro-aire surgical instruments | MICRO-AIRE GENERIC BURS & DRILLS | March 1, 1985 |
| K841298 | techmedica | HOLE CHAMFERING DEVICE | April 25, 1984 |
| K821485 | spire medical | DERMABRADERS | June 10, 1982 |
| K820281 | micro-aire surgical instruments | MICRO-AIRE REPLACEMENT DRILL BURS | February 23, 1982 |