K150341 is an FDA 510(k) clearance for the Miromatrix Biological Mesh RS, a Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery (Class II — Special Controls, product code OXH), submitted by Miromatrix Medical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on May 12, 2015, 90 days after receiving the submission on February 11, 2015. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K150341 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 11, 2015 |
| Decision Date | May 12, 2015 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OXH — Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.3300 |
| Definition | For Reinforcement Of Soft Tissue Where Weakness Exists In Plastic And Reconstructive Surgery. |