K250643 is an FDA 510(k) clearance for the Disposable Polymer Ligation Clips, a Clip, Implantable (Class II — Special Controls, product code FZP), submitted by Hangzhou Kangji Medical Instrument Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on November 20, 2025, 261 days after receiving the submission on March 4, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K250643 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 04, 2025 |
| Decision Date | November 20, 2025 |
| Days to Decision | 261 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 |