# K252598: Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)

- Pathway: 510(k) (Special)
- Applicant: Shanghai AnQing Medical Instrument Co., Ltd.
- Decided: Sep 15, 2025 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: 11 generations back to K921244 (1992). 45 ancestors in all.
No later device cites it as a predicate yet.
2 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222162: Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US), Shanghai AnQing Medical Instrument Co., Ltd. (2022)

## Indications for use
AnQing Medical Single Use Flexible Cystoscope is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of the lower urinary tract, including the bladder and urethra. The Flexible Cystoscope is intended for use in a hospital environment or medical office environment. The Flexible Cystoscope is designed for use in adults.

Source page: https://510kreport.com/device/K252598
Methodology: https://510kreport.com/methodology