GFA — Blade, Saw, General & Plastic Surgery, Surgical Class I
FDA product code GFA covers "Blade, Saw, General & Plastic Surgery, Surgical", a Class I medical device regulated under 21 CFR 878.4820. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GFA
- Device Class
- Class I
- Regulation Number
- 878.4820
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K971978 | wrightmedicaltechnologyinc | GRAFT HARVESTING SAWBLADES | June 18, 1997 |
| K954483 | stryker instruments | STRYKER SAGITTAL SAW ATTACHMENT | January 30, 1996 |
| K955229 | wrightmedicaltechnologyinc | WRIGHT MEDICAL TECHNOLOGY SAWBLADES | January 18, 1996 |
| K953012 | boston surgical products | DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS | July 12, 1995 |
| K950403 | transidyne general | SURGICAL SAW BLADES | February 21, 1995 |
| K940501 | adven medical | RE-SHARPENABLE SAW BLADES | June 28, 1994 |
| K933595 | omega surgical instruments | BUR, SURGICAL, GENERAL & PLASTIC SURGERY | March 16, 1994 |
| K935391 | 3m health care, sarns | SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PA | February 24, 1994 |
| K934603 | american medical specialties | SURGICAL SAW BLADES | February 22, 1994 |
| K931769 | surgiquip | SNAP OSCILLATING SAW | January 27, 1994 |
| K934390 | boehringer laboratories | OSCILLATING BONE SAW BLADE, 6200 SERIES | January 26, 1994 |
| K931210 | intermedics orthopedics | INTERMEDICS ORTHOPEDICS SAW BLADE | November 18, 1993 |
| K933298 | omega surgical instruments | SAW BLADE | August 9, 1993 |
| K924953 | boehringer laboratories | FLUID COOLED BONE SAW BLADE, 6000 SERIES | January 21, 1993 |
| K912761 | blairden precision instruments | SURGICAL SAW BLADES | July 19, 1991 |
| K896280 | micro-aire surgical instruments | MICRO-AIRE OSCILLATING SAW BLADE 202C-25, 202C-50 | November 22, 1989 |
| K863788 | tava surgical instruments | SAWBLADE | October 14, 1986 |
| K861876 | new england surgical instrument | CRANIO BLADES AND WIRE PASS DRILL | May 30, 1986 |
| K854192 | anadias | ANADIAS NASAL SAW BLADES | November 13, 1985 |
| K851880 | j-pac | BRIMFIELD SCIEN. INSTRU. DISPOS. STERILE SURG. BLA | May 21, 1985 |