K173323 is an FDA 510(k) clearance for the AnastoClip GC Closure System. This device is classified as a Clip, Implantable (Class II — Special Controls, product code FZP).
Submitted by LeMaitre Vascular, Inc. (Burlington, US). The FDA issued a Cleared decision on March 8, 2018, 139 days after receiving the submission on October 20, 2017.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K173323 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 20, 2017 |
| Decision Date | March 08, 2018 |
| Days to Decision | 139 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 |