K143644 is an FDA 510(k) clearance for the Premium Surgiclip¿. This device is classified as a Clip, Implantable (Class II - Special Controls, product code FZP).
Submitted by Covidien (North Haven, US). The FDA issued a Cleared decision on September 14, 2015, 266 days after receiving the submission on December 22, 2014.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K143644 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2014 |
| Decision Date | September 14, 2015 |
| Days to Decision | 266 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 |