K162570 is an FDA 510(k) clearance for the Miromatrix Biological Mesh TW, a Mesh, Surgical (Class II — Special Controls, product code FTM), submitted by Miromatrix Medical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on February 16, 2017, 154 days after receiving the submission on September 15, 2016. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K162570 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 15, 2016 |
| Decision Date | February 16, 2017 |
| Days to Decision | 154 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 |