K130557 is an FDA 510(k) clearance for the NEURAGEN 3D. This device is classified as a Cuff, Nerve (Class II - Special Controls, product code JXI).
Submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on April 24, 2014, 416 days after receiving the submission on March 4, 2013.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5275.
| 510(k) Number | K130557 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 2013 |
| Decision Date | April 24, 2014 |
| Days to Decision | 416 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 |