510(k) K253132

Single use stone retrieval balloons by Zhejiang Chuangxiang Medical Technology Co., Ltd. — Product Code FGE

K253132 is an FDA 510(k) premarket notification submitted by Zhejiang Chuangxiang Medical Technology Co., Ltd. for the device "Single use stone retrieval balloons". The FDA issued a decision of Substantially Equivalent on March 6, 2026. The device falls under product code FGE (Stents, Drains And Dilators For The Biliary Ducts), a Class II device regulated under 21 CFR 876.5010. Zhejiang Chuangxiang Medical Technology Co., Ltd. has at least 10 other 510(k) clearances on record.