# K260521: ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)

- Pathway: 510(k) (Traditional)
- Applicant: Zhuhai Pusen Medical Technology Co., Ltd.
- Decided: Apr 6, 2026 after 48 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)
- K243710: Disposable ureteral access sheath, Shenzhen Trious Medical Technology Co., Ltd. (2025) Summary page 5.

## Indications for use
This device is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract.

Source page: https://510kreport.com/device/K260521
Methodology: https://510kreport.com/methodology