K170016 is an FDA 510(k) clearance for the Biodesign Fistula Plug. This device is classified as a Mesh, Surgical (Class II — Special Controls, product code FTM).
Submitted by Cook Biotech Incorporated (West Lafayetta, US). The FDA issued a Cleared decision on June 21, 2017, 169 days after receiving the submission on January 3, 2017.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K170016 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 2017 |
| Decision Date | June 21, 2017 |
| Days to Decision | 169 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 |