K250797
- 510(k) number
- K250797
- Device name
- UV5000 Handle
- Applicant
- Uroviu Corporation CA · US
- Product code
- FAJ — Cystoscope And Accessories, Flexible/Rigid
- Decision date
- 2025-09-11
- Date received
- 2025-03-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K250797.pdf
Official FDA record: K250797
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.