SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK
FDA 510(k) clearance K935391 · decided 1994-02-24
Clearance details
- K-number
- K935391
- Device name
- SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK
- Applicant
- 3M Health Care, Sarns
- Decision
- Substantially Equivalent
- Date received
- 1993-11-08
- Decision date
- 1994-02-24
- Days to decision
- 108 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
- Ann Arbor, MI, 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 |
| SURGICAL SAW BLADES (K934603) | American Medical Specialties, Inc. | 1994-02-22 |
| 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
| Record | Firm | Date |
|---|---|---|
| Sternal Saw II Sterile Blades for the Sarns Sternal Saw System, Catalog number 5589, Terum recall (Z-0968-2011) | Terumo Cardiovascular Systems Corporation | 2011-01-26 |
| Terumo Sarns Sternal Saw II System Power Unit, 220/240 V, Terumo Cardiovascular Systems Co recall (Z-0359-2009) | Terumo Cardiovascular Systems Corporation | 2008-12-02 |