# K232837: Uro-G HD Flexible Cystoscope

- Pathway: 510(k) (Traditional)
- Applicant: Uroviu Corporation
- Decided: Jun 7, 2024 after 267 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: 6 generations back to K931154 (1993). 13 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 16 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202921: Uro-G Cystoscope, Uroviu Corporation (2021) Summary page 5.

## Most influential descendants
- K250797: UV5000 Handle (2025), 0 descendants of its own
- K243196: Uro-G HD Cystoscope (1520) (2024), 0 descendants of its own

## Indications for use
The Uro-G HD Flexible Cystoscope is intended for endoscopic diagnosis and infusion of irrigating fluids within the bladder and urethra.

Source page: https://510kreport.com/device/K232837
Methodology: https://510kreport.com/methodology