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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 / February 2026 / K251890

510(k) cleared

Disposable Ureteral Stents

Zhejiang Chuangxiang Medical Technology Co., Ltd. · Feb 20, 2026 · K251890

FDA cleared the Disposable Ureteral Stents from Zhejiang Chuangxiang Medical Technology Co., Ltd. on Feb 20, 2026 under K251890, a traditional 510(k). The device falls under product code FAD, Stent, Ureteral, regulated at 21 CFR 876.4620 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jun 20, 2025. The decision came 245 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Zhejiang Chuangxiang Medical Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K253132 (Single use stone retrieval balloons).

Questions & Answers

What did FDA clear under K251890?

K251890 is the FDA 510(k) for Disposable Ureteral Stents, submitted by Zhejiang Chuangxiang Medical Technology Co., Ltd.. FDA's decision date was Feb 20, 2026, under product code FAD (Stent, Ureteral).

Who makes the Disposable Ureteral Stents?

Zhejiang Chuangxiang Medical Technology Co., Ltd., based in Hangzhou, is the applicant of record for K251890.

How long did the K251890 review take?

FDA received the submission on Jun 20, 2025 and issued its decision on Feb 20, 2026, 245 days later.

← All decisions in February 2026

Sources