Disposable Stone Retrieval Balloon Catheter— 510(k) K253013

Substantially Equivalent

Zhejiang Soudon Medical Technology Co., Ltd.

FDA 510(k) clearance K253013 for Disposable Stone Retrieval Balloon Catheter, Substantially Equivalent on 2026-05-08. Applicant: Zhejiang Soudon Medical Technology Co., Ltd..

Clearance details

Applicant: Zhejiang Soudon Medical Technology Co., Ltd.
Product code: Code GCA
Advisory panel: Gastroenterology, Urology
Date received: 2025-09-19
Decision date: 2026-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

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