# K250797: UV5000 Handle

- Pathway: 510(k) (Traditional)
- Applicant: Uroviu Corporation
- Decided: Sep 11, 2025 after 181 days
- Product code: FAJ (Cystoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K931154 (1993). 14 ancestors in all.
No later device cites it as a predicate yet.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232837: Uro-G HD Flexible Cystoscope, Uroviu Corporation (2024) Summary page 5.

## Indications for use
The UV5000 Handle is to be used with UroViu Cannula Uro-G HD, Uro-G, Uro-V, Uro-N, and Hystero-V and is intended to be used to permit viewing of the urethra and bladder or cervical canal and uterine cavity for the purpose of performing diagnostics.

Source page: https://510kreport.com/device/K250797
Methodology: https://510kreport.com/methodology