# K230748: Disposable Ureteral Access Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Youcare Technology Co.,Ltd. (Wuhan)
- Decided: Aug 2, 2023 after 138 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 K022135 (2002). 7 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151084: Well Lead Ureteral Access Sheath, Well Lead Medical Co., Ltd. (2016) Summary page 4.

## Most influential descendants
- K241181: Disposable Ureteral Guide Sheath (2024), 2 descendants of its own
- K243710: Disposable ureteral access sheath (2025), 1 descendant of its own
- K260521: ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) (2026), 0 descendants of its own
- 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 Access 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/K230748
Methodology: https://510kreport.com/methodology