# K241181: Disposable Ureteral Guide Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Dongguan Zsr Biomedical Technology Company Limited
- Decided: Aug 2, 2024 after 95 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.
2 later devices descend from it; 2 cite it directly.
0 of 11 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
- K250695: Single-use Ureteral Access Sheath (2025), 0 descendants of its own
- K250585: LumenaTM Ureteral Access Sheath (2025), 0 descendants of its own

## Indications for use
The Disposable Ureteral Guide Sheath 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/K241181
Methodology: https://510kreport.com/methodology