REPROCESSED AUTOSUTURE GIA ENDOSCOPIC STAPLERS
FDA 510(k) clearance K070930 · decided 2007-10-18
Clearance details
- K-number
- K070930
- Device name
- REPROCESSED AUTOSUTURE GIA ENDOSCOPIC STAPLERS
- Applicant
- Sterilmed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-04-03
- Decision date
- 2007-10-18
- Days to decision
- 198 days
- Clearance type
- Traditional
- Product code
- NLL
- Device class
- 2
- Regulation number
- 878.4750
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Maple Grove, MN, 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 |
|---|---|---|
| REPROCESSED ETHICON ETS ENDOSCOPIC LINEAR CUTTERS (K070859) | Sterilmed, Inc. | 2007-09-12 |
| REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS (K033578) | Clearmedical, Inc. | 2005-07-11 |
Recalls involving this device
No recalls on record reference this clearance.