SURGICAL SAW BLADES
FDA 510(k) clearance K934603 · decided 1994-02-22
Clearance details
- K-number
- K934603
- Device name
- SURGICAL SAW BLADES
- Applicant
- American Medical Specialties, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-09-24
- Decision date
- 1994-02-22
- Days to decision
- 151 days
- Clearance type
- Traditional
- Product code
- GFA
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Roswell, GA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| GRAFT HARVESTING SAWBLADES (K971978) | Wrightmedicaltechnologyinc | 1997-06-18 |
| STRYKER SAGITTAL SAW ATTACHMENT (K954483) | Stryker Instruments | 1996-01-30 |
| WRIGHT MEDICAL TECHNOLOGY SAWBLADES (K955229) | Wrightmedicaltechnologyinc | 1996-01-18 |
| DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS (K953012) | Boston Surgical Products, Inc. | 1995-07-12 |
| SURGICAL SAW BLADES (K950403) | Transidyne General Corp. | 1995-02-21 |
| RE-SHARPENABLE SAW BLADES (K940501) | Adven Medical | 1994-06-28 |
| BUR, SURGICAL, GENERAL & PLASTIC SURGERY (K933595) | Omega Surgical Instruments, Inc. | 1994-03-16 |
| SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK (K935391) | 3M Health Care, Sarns | 1994-02-24 |
| SNAP OSCILLATING SAW (K931769) | Surgiquip, Inc. | 1994-01-27 |
| OSCILLATING BONE SAW BLADE, 6200 SERIES (K934390) | Boehringer Laboratories | 1994-01-26 |
| INTERMEDICS ORTHOPEDICS SAW BLADE (K931210) | Intermedics Orthopedics | 1993-11-18 |
| SAW BLADE (K933298) | Omega Surgical Instruments, Inc. | 1993-08-09 |
Recalls involving this device
No recalls on record reference this clearance.