K150668 is an FDA 510(k) clearance for the Biodesign Enterocutaneous Fistula Plug, a Mesh, Surgical (Class II — Special Controls, product code FTM), submitted by Cook Biotech Incorprated (West Lafayetta, US). The FDA issued a Cleared decision on December 9, 2015, 268 days after receiving the submission on March 16, 2015. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K150668 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 16, 2015 |
| Decision Date | December 09, 2015 |
| Days to Decision | 268 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 |