Submission Details
| 510(k) Number | K151943 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 14, 2015 |
| Decision Date | March 25, 2016 |
| Days to Decision | 255 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
K151943 is an FDA 510(k) clearance for the Vas-Q-Clip, a Clip, Implantable (Class II — Special Controls, product code FZP), submitted by Nanova Biomaterials, Inc. (Columbia, US). The FDA issued a Cleared decision on March 25, 2016, 255 days after receiving the submission on July 14, 2015. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K151943 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 14, 2015 |
| Decision Date | March 25, 2016 |
| Days to Decision | 255 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 |