K253013
- 510(k) number
- K253013
- Device name
- Disposable Stone Retrieval Balloon Catheter
- Applicant
- Zhejiang Soudon Medical Technology Co., Ltd. CN
- Product code
- GCA — Biliary Catheter For Stone Removal That May Also All
- Decision date
- 2026-05-08
- Date received
- 2025-09-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253013.pdf
Official FDA record: K253013
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.