K082682 is an FDA 510(k) clearance for the SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG, 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 February 27, 2009, 165 days after receiving the submission on September 15, 2008. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K082682 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 15, 2008 |
| Decision Date | February 27, 2009 |
| Days to Decision | 165 days |
| Submission Type | Traditional |
| 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 |