# K231135: Video Ureteroscope System

- Pathway: 510(k) (Traditional)
- Applicant: Hunan Vathin Medical Instrument Co., Ltd.
- Decided: Jan 17, 2024 after 271 days
- Product code: FGB (Ureteroscope 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: 9 generations back to K931154 (1993). 25 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 27 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172098: Medical Video Endoscope System, Zhuhai Pusen Medical Technology Co., Ltd. (2017) Summary page 5.

## Most influential descendants
- K243117: Digital Video Processor (2025), 0 descendants of its own

## Indications for use
The Single-use Flexible Ureteroscope is designed for use with Vathin Display Units, endotherapy accessories and other ancillary devices for the endoscopy and endoscopic surgery within urinary tract and kidney in adults. The Digital Video Monitor is specially designed to be used with medical endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.

Source page: https://510kreport.com/device/K231135
Methodology: https://510kreport.com/methodology