FDA Product Code
FDA Product Code GFF — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4820
510(k) Clearances — 16 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K974025 | ANSPACH SHIELDED ATTACHMENT | The Anspach Effort, Inc. | 1998-07-06 | Traditional | PDF ↗ |
| K950449 | SURGICAL BUR | Transidyne General Corp. | 1995-03-01 | Traditional | PDF ↗ |
| K943758 | SURGICAL BUR | Komet Medical | 1994-08-22 | Traditional | PDF ↗ |
| K934583 | BURRS | American Medical Specialties, Inc. | 1994-01-26 | Traditional | PDF ↗ |
| K894438 | MICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTS | Micro-Aire Surgical Instruments, Inc. | 1989-08-21 | Traditional | PDF ↗ |
| K890090 | DANEK IRRIGATING BURR (DIB) SET | Danek Medical, Inc. | 1989-01-24 | Traditional | PDF ↗ |
| K883255 | KOMET SURGICAL BUR | Komet Medical, Div. of Brasseler USA I, L.P. | 1988-09-15 | Traditional | PDF ↗ |
| K880859 | SURGICAL BURS | New England Surgical Instrument Corp. | 1988-03-21 | Traditional | PDF ↗ |
| K880706 | SURGICAL BURS | Nuell Air Equipment & Hospital Supplies, Inc. | 1988-02-26 | Traditional | PDF ↗ |
| K872475 | SURGICAL BUR | Tava Surgical Instruments | 1987-07-02 | Traditional | PDF ↗ |
| K862852 | MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR | Micro-Aire Surgical Instruments, Inc. | 1986-08-11 | Traditional | PDF ↗ |
| K853658 | BURS FOR MICRO SURGICAL DRILL SYSTEM | Acumed Instruments Corp. | 1985-09-24 | Traditional | PDF ↗ |
| K850497 | MICRO-AIRE GENERIC BURS & DRILLS | Micro-Aire Surgical Instruments, Inc. | 1985-03-01 | Traditional | PDF ↗ |
| K841298 | HOLE CHAMFERING DEVICE | Techmedica, Inc. | 1984-04-25 | Traditional | PDF ↗ |
| K821485 | DERMABRADERS | Spire Medical, Inc. | 1982-06-10 | Traditional | PDF ↗ |
| K820281 | MICRO-AIRE REPLACEMENT DRILL BURS | Micro-Aire Surgical Instruments, Inc. | 1982-02-23 | Traditional | PDF ↗ |
Product code GFF · Class I · General, Plastic Surgery. Data: openFDA.