K152481 is an FDA 510(k) clearance for the DURAFORM Dural Graft Implant. This device is classified as a Dura Substitute (Class II - Special Controls, product code GXQ).
Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on October 30, 2015, 60 days after receiving the submission on August 31, 2015.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5910.
| 510(k) Number | K152481 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 2015 |
| Decision Date | October 30, 2015 |
| Days to Decision | 60 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 |