# K130909: Gateway Advanage Y-Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: May 16, 2013 after 45 days
- Product code: OCX (Endoscopic Irrigation/Suction System)
- 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: 1 generation back to K920030 (1992). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920030: Sureseal Endoscopic Valve, Applied Urology, Inc. (1992) Summary page 1.

## Most influential descendants
- K173105: Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter (2018), 3 descendants of its own
- K252933: Dyne Port (2026), 0 descendants of its own
- K241842: Luer-Split MAJ-2092 (2025), 0 descendants of its own
- K181712: San Antonio Stopcock (2018), 0 descendants of its own

## Indications for use
The Gateway Advantage Y-Adapter is intended to prevent irrigant backflow while securing urological devices during procedures.. Irrigation may also be connected to the side port of the device. The Y-Adapter is supplied in a sealed pouch and is intended for single use only.

Source page: https://510kreport.com/device/K130909
Methodology: https://510kreport.com/methodology