K223640 is an FDA 510(k) clearance for the Axoguard HA+ Nerve Protector (AGHA12). This device is classified as a Cuff, Nerve (Class II - Special Controls, product code JXI).
Submitted by Axogen Corporation (Alachua, US). The FDA issued a Cleared decision on April 7, 2023, 123 days after receiving the submission on December 5, 2022.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5275.
| 510(k) Number | K223640 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 2022 |
| Decision Date | April 07, 2023 |
| Days to Decision | 123 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 |