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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / November 2025 / K250643

510(k) cleared

Disposable Polymer Ligation Clips

Hangzhou Kangji Medical Instrument Co., Ltd. · Nov 20, 2025 · K250643

FDA cleared the Disposable Polymer Ligation Clips from Hangzhou Kangji Medical Instrument Co., Ltd. on Nov 20, 2025 under K250643, a traditional 510(k). The device falls under product code FZP, Clip, Implantable, regulated at 21 CFR 878.4300 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Mar 4, 2025. The decision came 261 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Hangzhou Kangji Medical Instrument Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250643?

K250643 is the FDA 510(k) for Disposable Polymer Ligation Clips, submitted by Hangzhou Kangji Medical Instrument Co., Ltd.. FDA's decision date was Nov 20, 2025, under product code FZP (Clip, Implantable).

Who makes the Disposable Polymer Ligation Clips?

Hangzhou Kangji Medical Instrument Co., Ltd., based in Hangzhou, is the applicant of record for K250643.

How long did the K250643 review take?

FDA received the submission on Mar 4, 2025 and issued its decision on Nov 20, 2025, 261 days later.

← All decisions in November 2025