K062696 is an FDA 510(k) clearance for the SURGISIS, SURGISIS ES. This device is classified as a Mesh, Surgical (Class II - Special Controls, product code FTM).
Submitted by Cook Biotech, Inc. (West Lafayette, US). The FDA issued a Cleared decision on October 13, 2006, 32 days after receiving the submission on September 11, 2006.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K062696 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 2006 |
| Decision Date | October 13, 2006 |
| Days to Decision | 32 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTM — Mesh, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |