K200918 is an FDA 510(k) clearance for the SurgiWrap FROST. This device is classified as a Mesh, Surgical, Polymeric (Class II - Special Controls, product code FTL).
Submitted by Mast Biosurgery (San Diego, US). The FDA issued a Cleared decision on January 7, 2021, 276 days after receiving the submission on April 6, 2020.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K200918 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 2020 |
| Decision Date | January 07, 2021 |
| Days to Decision | 276 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTL - Mesh, Surgical, Polymeric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |