# K243857: Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai AnQing Medical Instrument Co., Ltd.
- Decided: Apr 11, 2025 after 116 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: 11 generations back to K931154 (1993). 30 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 32 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220159: Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US), Shanghai AnQing Medical Instrument Co., Ltd. (2022) Summary page 5.

## Most influential descendants
- 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

## 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/K243857
Methodology: https://510kreport.com/methodology