K250785
- 510(k) number
- K250785
- Device name
- Single-use Flexible Ureteroscope
- Applicant
- Hunan Vathin Medical Instrument Co., Ltd. CN
- Product code
- FGB — Ureteroscope And Accessories, Flexible/Rigid
- Decision date
- 2025-05-06
- Date received
- 2025-03-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K250785.pdf
Official FDA record: K250785
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.