K170656 is an FDA 510(k) clearance for the Reinforced Flexible Collagen Nerve Cuff. This device is classified as a Cuff, Nerve (Class II - Special Controls, product code JXI).
Submitted by Collagen Matrix, Inc. (Oakland, US). The FDA issued a Cleared decision on June 1, 2017, 90 days after receiving the submission on March 3, 2017.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5275.
| 510(k) Number | K170656 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 2017 |
| Decision Date | June 01, 2017 |
| 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 |