FDA 510(k) clearance · back to tracker

Disposable Stone Retrieval Balloon Catheter

Zhejiang Soudon Medical Technology Co., Ltd. cleared K253013 on 2026-05-08, decision: substantially equivalent

K-number

K253013

Sponsor

Zhejiang Soudon Medical Technology Co., Ltd.

Device

Disposable Stone Retrieval Balloon Catheter

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-05-08

Product code

GCA

Advisory committee

Gastroenterology, Urology

Medical specialty

Gastroenterology, Urology

Regulation number

876.5010

Official FDA record

Open K253013on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.