# K260410: Single Use Ureteral Access Sheath

- Pathway: 510(k) (Special)
- Applicant: Zhejiang Chuangxiang Medical Technology Co., Ltd.
- Decided: Sep 11, 2026 after 214 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: 6 generations back to K022135 (2002). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220065: Single Use Ureteral Access Sheath, Zhejiang Chuangxiang Medical Technology Co., Ltd. (2022) Summary page 5.

## Indications for use
The Single Use Ureteral Access Sheath is indicated for use in adult patients (aged 18 years and older) to facilitate the passage of endoscopes during urologic procedures.

Source page: https://510kreport.com/device/K260410
Methodology: https://510kreport.com/methodology