About This 510(k) Submission
K253132 is an FDA 510(k) clearance for the Single?use?stone?retrieval?balloons, a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by Zhejiang Chuangxiang Medical Technology Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on March 6, 2026, 162 days after receiving the submission on September 25, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.