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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 / May 2026 / K253013

510(k) cleared

Disposable Stone Retrieval Balloon Catheter

Zhejiang Soudon Medical Technology Co., Ltd. · May 8, 2026 · K253013

FDA cleared the Disposable Stone Retrieval Balloon Catheter from Zhejiang Soudon Medical Technology Co., Ltd. on May 8, 2026 under K253013, a traditional 510(k). The device falls under product code GCA, Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection, 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 19, 2025. The decision came 231 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: K253056 (Disposable Stone Extraction Basket).

Questions & Answers

What did FDA clear under K253013?

K253013 is the FDA 510(k) for Disposable Stone Retrieval Balloon Catheter, submitted by Zhejiang Soudon Medical Technology Co., Ltd.. FDA's decision date was May 8, 2026, under product code GCA (Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection).

Who makes the Disposable Stone Retrieval Balloon Catheter?

Zhejiang Soudon Medical Technology Co., Ltd., based in Hangzhou, is the applicant of record for K253013.

How long did the K253013 review take?

FDA received the submission on Sep 19, 2025 and issued its decision on May 8, 2026, 231 days later.

← All decisions in May 2026

Sources