510(k) K253056

Disposable Stone Extraction Basket by Zhejiang Soudon Medical Technology Co., Ltd. — Product Code LQR

K253056 is an FDA 510(k) premarket notification submitted by Zhejiang Soudon Medical Technology Co., Ltd. for the device "Disposable Stone Extraction Basket". The FDA issued a decision of Substantially Equivalent on April 3, 2026. The device falls under product code LQR (Dislodger, Stone, Biliary), a Class II device regulated under 21 CFR 876.5010. Zhejiang Soudon Medical Technology Co., Ltd. has at least 4 other 510(k) clearances on record.