# K242535: Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2)

- Pathway: 510(k) (Traditional)
- Applicant: Hunan Vathin Medical Instrument Co., Ltd.
- Decided: Dec 18, 2024 after 114 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 Flexible Cystoscope is designed to be used with the Vathin Display Unit, endotherapy accessories and other auxiliary device for endoscopy and treatment of adult bladder. The Digital Video Monitor is specially designed to be used with Vathin medical endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation. The devices are for use in professional Healthcare Facility Environment.

Source page: https://510kreport.com/device/K242535
Methodology: https://510kreport.com/methodology