Product code GFF
- Device name
- Bur, Surgical, General & Plastic Surgery
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4820
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K974025 | ANSPACH SHIELDED ATTACHMENT | The Anspach Effort, Inc. | 1998-07-06 |
| K950449 | SURGICAL BUR | Transidyne General Corp. | 1995-03-01 |
| K943758 | SURGICAL BUR | Komet Medical | 1994-08-22 |
| K934583 | BURRS | American Medical Specialties, Inc. | 1994-01-26 |
| K894438 | MICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTS | Micro-Aire Surgical Instruments, Inc. | 1989-08-21 |
| K890090 | DANEK IRRIGATING BURR (DIB) SET | Danek Medical, Inc. | 1989-01-24 |
| K883255 | KOMET SURGICAL BUR | Komet Medical, Div. of Brasseler USA I, L.P. | 1988-09-15 |
| K880859 | SURGICAL BURS | New England Surgical Instrument Corp. | 1988-03-21 |
| K880706 | SURGICAL BURS | Nuell Air Equipment & Hospital Supplies, Inc. | 1988-02-26 |
| K872475 | SURGICAL BUR | Tava Surgical Instruments | 1987-07-02 |
| K862852 | MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR | Micro-Aire Surgical Instruments, Inc. | 1986-08-11 |
| K853658 | BURS FOR MICRO SURGICAL DRILL SYSTEM | Acumed Instruments Corp. | 1985-09-24 |
| K850497 | MICRO-AIRE GENERIC BURS & DRILLS | Micro-Aire Surgical Instruments, Inc. | 1985-03-01 |
| K841298 | HOLE CHAMFERING DEVICE | Techmedica, Inc. | 1984-04-25 |
| K821485 | DERMABRADERS | Spire Medical, Inc. | 1982-06-10 |
| K820281 | MICRO-AIRE REPLACEMENT DRILL BURS | Micro-Aire Surgical Instruments, Inc. | 1982-02-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 14053613002322 | KOMET Surgical Bur | Gebr. Brasseler GmbH & Co. KG | 2023-01-31 |
| 14053613001998 | KOMET Surgical Bur | Gebr. Brasseler GmbH & Co. KG | 2023-01-31 |
| 05051471090064 | De Soutter Medical | DE SOUTTER MEDICAL LIMITED | 2022-11-29 |
| 05051471090279 | De Soutter Medical | DE SOUTTER MEDICAL LIMITED | 2022-11-29 |
| 05051471090262 | De Soutter Medical | DE SOUTTER MEDICAL LIMITED | 2022-11-29 |
| 05051471090255 | De Soutter Medical | DE SOUTTER MEDICAL LIMITED | 2022-11-29 |
| 05051471090248 | De Soutter Medical | DE SOUTTER MEDICAL LIMITED | 2022-11-29 |
| 05051471090231 | De Soutter Medical | DE SOUTTER MEDICAL LIMITED | 2022-11-29 |
| 05051471090217 | De Soutter Medical | DE SOUTTER MEDICAL LIMITED | 2022-11-29 |
| 05051471090200 | De Soutter Medical | DE SOUTTER MEDICAL LIMITED | 2022-11-29 |
| 05051471090187 | De Soutter Medical | DE SOUTTER MEDICAL LIMITED | 2022-11-29 |
| 05051471090132 | De Soutter Medical | DE SOUTTER MEDICAL LIMITED | 2022-11-29 |
| 05051471090118 | De Soutter Medical | DE SOUTTER MEDICAL LIMITED | 2022-11-29 |
| 05051471090095 | De Soutter Medical | DE SOUTTER MEDICAL LIMITED | 2022-11-29 |
| 05051471090071 | De Soutter Medical | DE SOUTTER MEDICAL LIMITED | 2022-11-29 |
| 05051471027725 | De Soutter Medical | DE SOUTTER MEDICAL LIMITED | 2022-11-29 |
| 05051471090057 | De Soutter Medical | DE SOUTTER MEDICAL LIMITED | 2022-11-29 |
| 05051471090033 | De Soutter Medical | DE SOUTTER MEDICAL LIMITED | 2022-11-29 |
| 05051471090019 | De Soutter Medical | DE SOUTTER MEDICAL LIMITED | 2022-11-29 |
| 05051471089983 | De Soutter Medical | DE SOUTTER MEDICAL LIMITED | 2022-11-29 |
| 05051471089976 | De Soutter Medical | DE SOUTTER MEDICAL LIMITED | 2022-11-29 |
| 05051471089938 | De Soutter Medical | DE SOUTTER MEDICAL LIMITED | 2022-11-29 |
| 05051471089907 | De Soutter Medical | DE SOUTTER MEDICAL LIMITED | 2022-11-29 |
| 05051471089877 | De Soutter Medical | DE SOUTTER MEDICAL LIMITED | 2022-11-29 |
| 05051471089853 | De Soutter Medical | DE SOUTTER MEDICAL LIMITED | 2022-11-29 |
| 05051471089839 | De Soutter Medical | DE SOUTTER MEDICAL LIMITED | 2022-11-29 |
| 05051471089815 | De Soutter Medical | DE SOUTTER MEDICAL LIMITED | 2022-11-29 |
| 05051471089808 | De Soutter Medical | DE SOUTTER MEDICAL LIMITED | 2022-11-29 |
| 05051471089792 | De Soutter Medical | DE SOUTTER MEDICAL LIMITED | 2022-11-29 |
| 05051471030152 | De Soutter Medical | DE SOUTTER MEDICAL LIMITED | 2022-11-29 |