# K151084: Well Lead Ureteral Access Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Well Lead Medical Co., Ltd.
- Decided: Jan 7, 2016 after 260 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: 3 generations back to K022135 (2002). 6 ancestors in all.
19 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123675: RE-Trace Ureteral Access Sheath, 10/12 French, Length 35 and 45 CM, Ureteral Access Sheath, 12/14 CH-FR, Length 35CM, UR, Coloplast A/S (2013) Summary page 4.
- K140323: Navigator HD Ureteral Access Sheath Sets, Boston Scientific (2014) Summary page 4.

## Most influential descendants
- K161110: ClearPetra Suction-Evacuation Sheath (2016), 7 descendants of its own
- K230748: Disposable Ureteral Access Sheath (2023), 5 descendants of its own
- K203165: Disposable Ureteral Access Sheath (2021), 4 descendants of its own
- K241181: Disposable Ureteral Guide Sheath (2024), 2 descendants of its own
- K243710: Disposable ureteral access sheath (2025), 1 descendant of its own

## Indications for use
The Well Lead 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/K151084
Methodology: https://510kreport.com/methodology