# K240374: Ureterorenoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen HugeMed Medical Technical Development Co., Ltd.
- Decided: May 10, 2024 after 93 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: 10 generations back to K931154 (1993). 26 ancestors in all.
No later device cites it as a predicate yet.
1 of 27 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230475: Medical Video Endoscope System, Huger Medical Instrument Co., Ltd. (2023) Summary page 5.

## Indications for use
The Ureterorenoscope 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.

Source page: https://510kreport.com/device/K240374
Methodology: https://510kreport.com/methodology