K253056
- 510(k) number
- K253056
- Device name
- Disposable Stone Extraction Basket
- Applicant
- Zhejiang Soudon Medical Technology Co., Ltd. CN
- Product code
- LQR — Dislodger, Stone, Biliary
- Decision date
- 2026-04-03
- Date received
- 2025-09-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K253056.pdf
Official FDA record: K253056
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.