# K180367: Ureterorenoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai AnQing Medical Instrument Co., Ltd.
- Decided: Jul 3, 2018 after 141 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: 8 generations back to K931154 (1993). 27 ancestors in all.
9 later devices descend from it; 2 cite it directly.
2 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131369: Flexible Video-Uretero-Renoscope System, KARL STORZ Endoscopy-America, Inc. (2013) Summary page 4.
- K153049: LithoVue System, Boston Scientific Corporation (2015) Summary page 4.

## Most influential descendants
- K201293: Ureterorenoscope System (2020), 4 descendants of its own
- K233472: CVAC Aspiration System + CVAC Image Processor (2024), 3 descendants of its own
- K220159: Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US) (2022), 3 descendants of its own
- K243857: Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) (2025), 1 descendant of its own
- K261447: CVAC® Aspiration System (2026), 0 descendants of its own

## Indications for use
The Ureterorenoscope System consists of a sterile single-use disposable Flexible Ureteroscope to be introduced within the urinary tract and video processor for clinical image processing. The device is indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K180367
Methodology: https://510kreport.com/methodology