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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 / March 2026 / K253132

510(k) cleared

Single use stone retrieval balloons

Zhejiang Chuangxiang Medical Technology Co., Ltd. · Mar 6, 2026 · K253132

FDA cleared the Single use stone retrieval balloons from Zhejiang Chuangxiang Medical Technology Co., Ltd. on Mar 6, 2026 under K253132, a traditional 510(k). The device falls under product code FGE, Stents, Drains And Dilators For The Biliary Ducts, regulated at 21 CFR 876.5010 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Sep 25, 2025. The decision came 162 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: K251890 (Disposable Ureteral Stents).

Questions & Answers

What did FDA clear under K253132?

K253132 is the FDA 510(k) for Single use stone retrieval balloons, submitted by Zhejiang Chuangxiang Medical Technology Co., Ltd.. FDA's decision date was Mar 6, 2026, under product code FGE (Stents, Drains And Dilators For The Biliary Ducts).

Who makes the Single use stone retrieval balloons?

Zhejiang Chuangxiang Medical Technology Co., Ltd., based in Hangzhou, is the applicant of record for K253132.

How long did the K253132 review take?

FDA received the submission on Sep 25, 2025 and issued its decision on Mar 6, 2026, 162 days later.

← All decisions in March 2026

Sources