K230794 is an FDA 510(k) clearance for the Rebuilder Nerve Guidance Conduit. This device is classified as a Cuff, Nerve (Class II - Special Controls, product code JXI).
Submitted by Celestray Biotech Company, LLC., (Bethesda, US). The FDA issued a Cleared decision on January 29, 2024, 313 days after receiving the submission on March 22, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5275.
| 510(k) Number | K230794 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 2023 |
| Decision Date | January 29, 2024 |
| Days to Decision | 313 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 |