K253132
- 510(k) number
- K253132
- Device name
- Single use stone retrieval balloons
- Applicant
- Zhejiang Chuangxiang Medical Technology Co., Ltd. CN
- Product code
- FGE — Stents, Drains And Dilators For The Biliary Ducts
- Decision date
- 2026-03-06
- Date received
- 2025-09-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K253132.pdf
Official FDA record: K253132
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.