# K222602: Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300)

- Pathway: 510(k) (Traditional)
- Applicant: Zhuhai Pusen Medical Technology Co., Ltd.
- Decided: Sep 26, 2022 after 28 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.
1 later device descends from it; 1 cites it directly.
2 of 46 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 4.

## Most influential descendants
- K240283: BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-T, S13-N, S13-S) (2024), 0 descendants of its own

## Indications for use
The Pusen Single Use Flexible Video Cystoscope System is intended to be used for endoscopic access to and examination of the lower urinary tract. The Pusen Single Use Flexible Video Cystoscope is intended to provide visualization via video processor and can be used with endoscopic accessories. This system is intended for use in a hospital environment or medical office environment.

Source page: https://510kreport.com/device/K222602
Methodology: https://510kreport.com/methodology