K242541 is an FDA 510(k) clearance for the GEM ZIPCLIP, a Clip, Implantable (Class II — Special Controls, product code FZP), submitted by Synovis Micro Companies Alliance A Subsidiary of Baxter Int (Birmingham, US). The FDA issued a Cleared decision on January 15, 2025, 142 days after receiving the submission on August 26, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K242541 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 26, 2024 |
| Decision Date | January 15, 2025 |
| Days to Decision | 142 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 |