K202234 is an FDA 510(k) clearance for the NervAlign Nerve Cuff. This device is classified as a Cuff, Nerve (Class II - Special Controls, product code JXI).
Submitted by Renerve, Ltd. (North Melbourne, AU). The FDA issued a Cleared decision on February 10, 2022, 552 days after receiving the submission on August 7, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5275.
| 510(k) Number | K202234 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 2020 |
| Decision Date | February 10, 2022 |
| Days to Decision | 552 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 |