# K250132: Ureteral Access Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang YiGao Medical Technology Co., Ltd.
- Decided: Sep 5, 2025 after 231 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: 4 generations back to K990775 (1999). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172217: Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath, Cook Incorporated (2017) Summary page 5.

## Indications for use
The ureteral access sheath is used to establish a working channel during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the urinary tract. The intended population of this device should be adult only. This is a single-use device. A re-sterilization by users and re-use of the device are not allowed.

Source page: https://510kreport.com/device/K250132
Methodology: https://510kreport.com/methodology