K163456 is an FDA 510(k) clearance for the DuraGen Secure Dural Regeneration Matrix. This device is classified as a Dura Substitute (Class II - Special Controls, product code GXQ).
Submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on January 6, 2017, 28 days after receiving the submission on December 9, 2016.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5910.
| 510(k) Number | K163456 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2016 |
| Decision Date | January 06, 2017 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXQ — Dura Substitute |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5910 |