K201631 is an FDA 510(k) clearance for the VersaWrap Nerve Protector. This device is classified as a Cuff, Nerve (Class II - Special Controls, product code JXI).
Submitted by Alafair Biosciences, Inc. (Austin, US). The FDA issued a Cleared decision on September 14, 2020, 90 days after receiving the submission on June 16, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5275.
| 510(k) Number | K201631 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 2020 |
| Decision Date | September 14, 2020 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | JXI - Cuff, Nerve |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5275 |