# K230475: Medical Video Endoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Huger Medical Instrument Co., Ltd.
- Decided: Nov 3, 2023 after 254 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.
2 later devices descend from it; 2 cite it directly.
1 of 28 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 7.

## Most influential descendants
- K241639: Single-use Video Ureterorenoscope (SVU-220US) (2024), 0 descendants of its own
- K240374: Ureterorenoscope System (2024), 0 descendants of its own

## Indications for use
Medical Video Endoscope System has been designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney. Medical Video Processor is intended to be used in conjunction with the endoscopes to enhance and display the image of the field of view of the endoscope on the monitor, and also provides functional supply for the endoscope. Single-use Video Ureterorenoscope is intended to connect with Medical Video Processor to provide video imaging.

Source page: https://510kreport.com/device/K230475
Methodology: https://510kreport.com/methodology