Disposable Stone Retrieval Balloon Catheter— 510(k) K253013
Substantially EquivalentZhejiang 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.. Device class: 2.
Summary
Zhejiang Soudon Medical Technology filed the Disposable Stone Retrieval Balloon Catheter under GCA, biliary catheters for stone removal that may also allow for irrigation and contrast injection. The device name is generic.
Class II, 21 CFR 876.5010. Gastroenterology and Urology is both the classification panel and the review panel. It was a Traditional 510(k).
Soudon filed from Hangzhou, China. Review took 231 calendar days (September 19, 2025 to May 8, 2026).
Clearance details
- Applicant
- Zhejiang Soudon Medical Technology Co., Ltd.
- Product code
- Product code GCA
- Device class
- Class 2
- Regulation
- 21 CFR 876.5010
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hangzhou, CN
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More clearances from Zhejiang Soudon Medical Technology Co., Ltd.
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