K162934 is an FDA 510(k) clearance for the Biodesign Parastomal Hernia Repair Graft. This device is classified as a Mesh, Surgical (Class II - Special Controls, product code FTM).
Submitted by Cook Biotech Incorporated (West Lafayette, US). The FDA issued a Cleared decision on July 10, 2017, 263 days after receiving the submission on October 20, 2016.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K162934 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 2016 |
| Decision Date | July 10, 2017 |
| Days to Decision | 263 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 |