# K182876: Uro-N Cystoscope

- Pathway: 510(k) (Traditional)
- Applicant: Uroviu Corporation
- Decided: Jul 2, 2019 after 263 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 K820973 (1982). 22 ancestors in all.
No later device cites it as a predicate yet.
1 of 23 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171602: Williams Cystoscopic Injection Needle, Cook Incorporated (2017) Summary page 4.
- K171500: Uro-V Cystoscope, Uroviu Corporation (2018) Summary page 4.

## Indications for use
The Uro-N Cystoscope is intended for directed injection of therapeutic agents and solutions into target areas of the bladder and the lower urinary tract via a cystoscope.

Source page: https://510kreport.com/device/K182876
Methodology: https://510kreport.com/methodology