# K203165: Disposable Ureteral Access Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Beyo Medical Technology Co., Ltd.
- Decided: Apr 30, 2021 after 189 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.
4 later devices descend from it; 3 cite it directly.
0 of 12 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
- K240167: Single-use Ureteral Access Sheath (2024), 1 descendant of its own
- K220065: Single Use Ureteral Access Sheath (2022), 1 descendant of its own
- K260410: Single Use Ureteral Access Sheath (2026), 0 descendants of its own
- K251599: Single-use Ureteral Access Sheath (2025), 0 descendants of its own

## Indications for use
The Ureteral Access Sheath is intended to use in urologic endoscopic procedures to facilitate the passage of endoscopes.

Source page: https://510kreport.com/device/K203165
Methodology: https://510kreport.com/methodology