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The Tracker / September 2026 / K260410

510(k) cleared

Single Use Ureteral Access Sheath

Zhejiang Chuangxiang Medical Technology Co., Ltd. · Sep 11, 2026 · K260410

FDA cleared the Single Use Ureteral Access Sheath from Zhejiang Chuangxiang Medical Technology Co., Ltd. on Sep 11, 2026 under K260410, a special 510(k). The device falls under product code FED, Endoscopic Access Overtube, Gastroenterology-Urology, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Feb 9, 2026. The decision came 214 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 2 other decisions in the tracker over the last 12 months: K253132 (Single use stone retrieval balloons), K251890 (Disposable Ureteral Stents).

Questions & Answers

What did FDA clear under K260410?

K260410 is the FDA 510(k) for Single Use Ureteral Access Sheath, submitted by Zhejiang Chuangxiang Medical Technology Co., Ltd.. FDA's decision date was Sep 11, 2026, under product code FED (Endoscopic Access Overtube, Gastroenterology-Urology).

Who makes the Single Use Ureteral Access Sheath?

Zhejiang Chuangxiang Medical Technology Co., Ltd., based in Hangzhou, is the applicant of record for K260410.

How long did the K260410 review take?

FDA received the submission on Feb 9, 2026 and issued its decision on Sep 11, 2026, 214 days later.

← All decisions in September 2026

Sources