# K243710: Disposable ureteral access sheath

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Trious Medical Technology Co., Ltd.
- Decided: Apr 11, 2025 after 130 days
- Product code: FED (Endoscopic Access Overtube, Gastroenterology-Urology)
- 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: 5 generations back to K022135 (2002). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230748: Disposable Ureteral Access Sheath, Youcare Technology Co.,Ltd. (Wuhan) (2023) Summary page 5.

## Most influential descendants
- K260521: ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) (2026), 0 descendants of its own

## Indications for use
The Disposable Ureteral Access Sheath is used to establish a continuous conduit during urological endoscopic procedures facilitating the in and out passage of endoscopes and other instruments into the urinary tract.

Source page: https://510kreport.com/device/K243710
Methodology: https://510kreport.com/methodology