# K231118: Cystoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen HugeMed Medical Technical Development Co., Ltd.
- Decided: Nov 13, 2023 after 207 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: 10 generations back to K921244 (1992). 44 ancestors in all.
No later device cites it as a predicate yet.
2 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193095: Ambu aScope 4 Cysto, Ambu A/S (2020) Summary page 5.

## Indications for use
The 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 single-use cystoscope is intended to provide visualization via image processor and can be used with endoscopic accessories. The cystoscope system is intended for use in a hospital environment or medical office environment. The cystoscope system is designed for use for adult patients requiring cystoscopy.

Source page: https://510kreport.com/device/K231118
Methodology: https://510kreport.com/methodology