K191696 is an FDA 510(k) clearance for the Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft. This device is classified as a Mesh, Surgical, Collagen, Fistula (Class II - Special Controls, product code OXN).
Submitted by Cook Biotech Incorporated (West Lafayette, US). The FDA issued a Cleared decision on December 27, 2019, 185 days after receiving the submission on June 25, 2019.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300. For Reinforcement Of Soft Tissue Where Weakness Exists During The Repair Of Fistulas..
| 510(k) Number | K191696 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 2019 |
| Decision Date | December 27, 2019 |
| Days to Decision | 185 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OXN - Mesh, Surgical, Collagen, Fistula |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |
| Definition | For Reinforcement Of Soft Tissue Where Weakness Exists During The Repair Of Fistulas. |