K213163 is an FDA 510(k) clearance for the VersaWrap, a Mesh, Surgical (Class II — Special Controls, product code FTM), submitted by Alafair Biosciences, Inc. (Austin, US). The FDA issued a Cleared decision on October 29, 2021, 31 days after receiving the submission on September 28, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K213163 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 28, 2021 |
| Decision Date | October 29, 2021 |
| Days to Decision | 31 days |
| Submission Type | Special |
| 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 |