K253226
- 510(k) number
- K253226
- Device name
- UV5000W Handle
- Applicant
- Uroviu Corporation CA · US
- Product code
- FAJ — Cystoscope And Accessories, Flexible/Rigid
- Decision date
- 2025-10-23
- Date received
- 2025-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K253226.pdf
Official FDA record: K253226
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.