# K253696: CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465)

- Pathway: 510(k) (Traditional)
- Applicant: Verathon Medical (Canada) Ulc
- Decided: May 11, 2026 after 171 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: 1 generation back to K240848 (2024). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240848: Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aView™ 2 Advance, Ambu A/S (2024) Summary page 5.

## Indications for use
The CFlex Single-use Cystoscope is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The cystoscope is intended to provide visualization via compatible Verathon monitor and can be used with endoscopic accessories. The cystoscope is intended for use in adults requiring cystoscopy by qualified urology professionals in a clinic, hospital or ambulatory surgery center (ASC) environment. The CystoView monitor is intended to display live imaging data from the CFlex Single-use Cystoscope.

Source page: https://510kreport.com/device/K253696
Methodology: https://510kreport.com/methodology