Bur, Surgical, General & Plastic Surgery
The Bur, Surgical, General and Plastic Surgery (product code GFF) is a rotating cutting or grinding attachment used with powered surgical instrument systems to shape, smooth, or remove bone and tissue during general and plastic surgery procedures. It is classified as an FDA Class 1 device, the lowest risk category, subject to general controls only and not requiring premarket notification. Regulated under 21 CFR 878.4820 in the General, Plastic Surgery specialty (SU), this device carries no special regulatory flags.
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Basic Information
- Product Code
- GFF
- Device Class
- FDA class 1
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 16 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K974025 | ANSPACH SHIELDED ATTACHMENT | Jul 06, 1998 | Substantially Equivalent | The Anspach Effort, Inc. |
| K950449 | SURGICAL BUR | Mar 01, 1995 | Substantially Equivalent | Transidyne General Corp. |
| K943758 | SURGICAL BUR | Aug 22, 1994 | Substantially Equivalent | Komet Medical |
| K934583 | BURRS | Jan 26, 1994 | Substantially Equivalent | American Medical Specialties, Inc. |
| K894438 | MICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTS | Aug 21, 1989 | Substantially Equivalent | Micro-Aire Surgical Instruments, Inc. |
| K890090 | DANEK IRRIGATING BURR (DIB) SET | Jan 24, 1989 | Substantially Equivalent | Danek Medical, Inc. |
| K883255 | KOMET SURGICAL BUR | Sep 15, 1988 | Substantially Equivalent | Komet Medical, Div. of Brasseler USA I, L.P. |
| K880859 | SURGICAL BURS | Mar 21, 1988 | Substantially Equivalent | New England Surgical Instrument Corp. |
| K880706 | SURGICAL BURS | Feb 26, 1988 | Substantially Equivalent | Nuell Air Equipment & Hospital Supplies, Inc. |
| K872475 | SURGICAL BUR | Jul 02, 1987 | Substantially Equivalent | Tava Surgical Instruments |
| K862852 | MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR | Aug 11, 1986 | Substantially Equivalent | Micro-Aire Surgical Instruments, Inc. |
| K853658 | BURS FOR MICRO SURGICAL DRILL SYSTEM | Sep 24, 1985 | Substantially Equivalent | Acumed Instruments Corp. |
| K850497 | MICRO-AIRE GENERIC BURS & DRILLS | Mar 01, 1985 | Substantially Equivalent | Micro-Aire Surgical Instruments, Inc. |
| K841298 | HOLE CHAMFERING DEVICE | Apr 25, 1984 | Substantially Equivalent | Techmedica, Inc. |
| K821485 | DERMABRADERS | Jun 10, 1982 | Substantially Equivalent | Spire Medical, Inc. |
| K820281 | MICRO-AIRE REPLACEMENT DRILL BURS | Feb 23, 1982 | Substantially Equivalent | Micro-Aire Surgical Instruments, Inc. |
FEI Numbers
This FDA classification entry is associated with 178 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 178 registration numbers. Click on an entry to view related FDA registrations.