GFF · Bur, Surgical, General & Plastic Surgery
General, Plastic Surgery · 21 CFR 878.4820 · Class 1
Overview
| Product Code | GFF |
|---|---|
| Device Name | Bur, Surgical, General & Plastic Surgery |
| Regulation | 21 CFR 878.4820 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
Recent Cleared Devices (16 of 16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K974025 | ANSPACH SHIELDED ATTACHMENT | The Anspach Effort, Inc. | Jul 6, 1998 | SESE |
| K950449 | SURGICAL BUR | Transidyne General Corp. | Mar 1, 1995 | SESE |
| K943758 | SURGICAL BUR | Komet Medical | Aug 22, 1994 | SESE |
| K934583 | BURRS | American Medical Specialties, Inc. | Jan 26, 1994 | SESE |
| K894438 | MICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTS | Micro-Aire Surgical Instruments, Inc. | Aug 21, 1989 | SESE |
| K890090 | DANEK IRRIGATING BURR (DIB) SET | Danek Medical, Inc. | Jan 24, 1989 | SESE |
| K883255 | KOMET SURGICAL BUR | Komet Medical, Div. of Brasseler USA I, L.P. | Sep 15, 1988 | SESE |
| K880859 | SURGICAL BURS | New England Surgical Instrument Corp. | Mar 21, 1988 | SESE |
| K880706 | SURGICAL BURS | Nuell Air Equipment & Hospital Supplies, Inc. | Feb 26, 1988 | SESE |
| K872475 | SURGICAL BUR | Tava Surgical Instruments | Jul 2, 1987 | SESE |
| K862852 | MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR | Micro-Aire Surgical Instruments, Inc. | Aug 11, 1986 | SESE |
| K853658 | BURS FOR MICRO SURGICAL DRILL SYSTEM | Acumed Instruments Corp. | Sep 24, 1985 | SESE |
| K850497 | MICRO-AIRE GENERIC BURS & DRILLS | Micro-Aire Surgical Instruments, Inc. | Mar 1, 1985 | SESE |
| K841298 | HOLE CHAMFERING DEVICE | Techmedica, Inc. | Apr 25, 1984 | SESE |
| K821485 | DERMABRADERS | Spire Medical, Inc. | Jun 10, 1982 | SESE |
| K820281 | MICRO-AIRE REPLACEMENT DRILL BURS | Micro-Aire Surgical Instruments, Inc. | Feb 23, 1982 | SESE |
Top Applicants
- Micro-Aire Surgical Instruments, Inc. — 4 clearances
- Transidyne General Corp. — 1 clearance
- The Anspach Effort, Inc. — 1 clearance
- Techmedica, Inc. — 1 clearance
- Tava Surgical Instruments — 1 clearance
