# K253226: UV5000W Handle

- Pathway: 510(k) (Special)
- Applicant: Uroviu Corporation
- Decided: Oct 23, 2025 after 24 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K210619: SKR 3000, Konica Minolta, Inc. (2021). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The UV5000W 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/K253226
Methodology: https://510kreport.com/methodology