# K220159: Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US)

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai AnQing Medical Instrument Co., Ltd.
- Decided: Aug 26, 2022 after 219 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). 29 ancestors in all.
3 later devices descend from it; 2 cite it directly.
1 of 33 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201293: Ureterorenoscope System, Shanghai AnQing Medical Instrument Co., Ltd. (2020) Summary page 4.

## Most influential descendants
- K243857: Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) (2025), 1 descendant of its own
- K252806: Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.) (2025), 0 descendants of its own
- K222737: Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US) (2022), 0 descendants of its own

## Indications for use
The Flexible Ureterorenoscope is intended to be used to visualize organs, cavities, and canals in the urinary tract (urethra, bladder, ureter, calyces, and renal papillae) via transurethral access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.

Source page: https://510kreport.com/device/K220159
Methodology: https://510kreport.com/methodology