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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 / April 2026 / K253056

510(k) cleared

Disposable Stone Extraction Basket

Zhejiang Soudon Medical Technology Co., Ltd. · Apr 3, 2026 · K253056

FDA cleared the Disposable Stone Extraction Basket from Zhejiang Soudon Medical Technology Co., Ltd. on Apr 3, 2026 under K253056, a traditional 510(k). The device falls under product code LQR, Dislodger, Stone, Biliary, 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 22, 2025. The decision came 193 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Zhejiang Soudon Medical Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K253013 (Disposable Stone Retrieval Balloon Catheter).

Questions & Answers

What did FDA clear under K253056?

K253056 is the FDA 510(k) for Disposable Stone Extraction Basket, submitted by Zhejiang Soudon Medical Technology Co., Ltd.. FDA's decision date was Apr 3, 2026, under product code LQR (Dislodger, Stone, Biliary).

Who makes the Disposable Stone Extraction Basket?

Zhejiang Soudon Medical Technology Co., Ltd., based in Hangzhou, is the applicant of record for K253056.

How long did the K253056 review take?

FDA received the submission on Sep 22, 2025 and issued its decision on Apr 3, 2026, 193 days later.

← All decisions in April 2026

Sources