K062869 is an FDA 510(k) clearance for the CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS CS40B, CS40G, CR40B AND CR40G. This device is classified as a Staple, Implantable (Class II - Special Controls, product code GDW).
Submitted by Ethicon Endo-Surgery, LLC (Cincinnati, US). The FDA issued a Cleared decision on February 26, 2007, 154 days after receiving the submission on September 25, 2006.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K062869 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2006 |
| Decision Date | February 26, 2007 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GDW — Staple, Implantable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4750 |