K213813 is an FDA 510(k) clearance for the DuraFuse Clip and Applier System. This device is classified as a Clip, Implantable (Class II - Special Controls, product code FZP).
Submitted by Neuramedica, Inc. (Oregon City, US). The FDA issued a Cleared decision on July 22, 2022, 227 days after receiving the submission on December 7, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K213813 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 2021 |
| Decision Date | July 22, 2022 |
| Days to Decision | 227 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FZP - Clip, Implantable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4300 |