GFA · Blade, Saw, General & Plastic Surgery, Surgical
General, Plastic Surgery · 21 CFR 878.4820 · Class 1
Overview
| Product Code | GFA |
|---|---|
| Device Name | Blade, Saw, General & Plastic Surgery, Surgical |
| 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 (20 of 27)
Showing 20 most recent of 27 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K971978 | GRAFT HARVESTING SAWBLADES | Wrightmedicaltechnologyinc | Jun 18, 1997 | SESE |
| K954483 | STRYKER SAGITTAL SAW ATTACHMENT | Stryker Instruments | Jan 30, 1996 | SESE |
| K955229 | WRIGHT MEDICAL TECHNOLOGY SAWBLADES | Wrightmedicaltechnologyinc | Jan 18, 1996 | SESE |
| K953012 | DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS | Boston Surgical Products, Inc. | Jul 12, 1995 | SESE |
| K950403 | SURGICAL SAW BLADES | Transidyne General Corp. | Feb 21, 1995 | SESE |
| K940501 | RE-SHARPENABLE SAW BLADES | Adven Medical | Jun 28, 1994 | SESE |
| K933595 | BUR, SURGICAL, GENERAL & PLASTIC SURGERY | Omega Surgical Instruments, Inc. | Mar 16, 1994 | SESE |
| K935391 | SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK | 3M Health Care, Sarns | Feb 24, 1994 | SESE |
| K934603 | SURGICAL SAW BLADES | American Medical Specialties, Inc. | Feb 22, 1994 | SESE |
| K931769 | SNAP OSCILLATING SAW | Surgiquip, Inc. | Jan 27, 1994 | SESE |
| K934390 | OSCILLATING BONE SAW BLADE, 6200 SERIES | Boehringer Laboratories | Jan 26, 1994 | SESE |
| K931210 | INTERMEDICS ORTHOPEDICS SAW BLADE | Intermedics Orthopedics | Nov 18, 1993 | SESE |
| K933298 | SAW BLADE | Omega Surgical Instruments, Inc. | Aug 9, 1993 | SESE |
| K924953 | FLUID COOLED BONE SAW BLADE, 6000 SERIES | Boehringer Laboratories | Jan 21, 1993 | SESE |
| K912761 | SURGICAL SAW BLADES | Blairden Precision Instruments, Inc. | Jul 19, 1991 | SESE |
| K896280 | MICRO-AIRE OSCILLATING SAW BLADE 202C-25, 202C-50 | Micro-Aire Surgical Instruments, Inc. | Nov 22, 1989 | SESE |
| K863788 | SAWBLADE | Tava Surgical Instruments | Oct 14, 1986 | SESE |
| K861876 | CRANIO BLADES AND WIRE PASS DRILL | New England Surgical Instrument Corp. | May 30, 1986 | SESE |
| K854192 | ANADIAS NASAL SAW BLADES | Anadias, Inc. | Nov 13, 1985 | SESE |
| K851880 | BRIMFIELD SCIEN. INSTRU. DISPOS. STERILE SURG. BLA | J-Pac, LLC | May 21, 1985 | SESE |
Top Applicants
- Micro-Aire Surgical Instruments, Inc. — 4 clearances
- Boehringer Laboratories — 2 clearances
- Omega Surgical Instruments, Inc. — 2 clearances
- Wrightmedicaltechnologyinc — 2 clearances
- 3M Health Care, Sarns — 1 clearance
