Cleared Traditional

K130909 - GATEWAY ADVANAGE Y-ADAPTER

K130909 is an FDA 510(k) clearance for GATEWAY ADVANAGE Y-ADAPTER, manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code OCX cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K130909 · Boston Scientific Corp · Gastroenterology & Urology device
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May 2013
Decision
45d
Days
Class 2
Risk

K130909 is an FDA 510(k) clearance for the GATEWAY ADVANAGE Y-ADAPTER. Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by Boston Scientific Corp (Marlboro, US). The FDA issued a Cleared decision on May 16, 2013 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boston Scientific Corp devices

FDA 510(k) Submission Details - K130909

510(k) Number K130909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2013
Decision Date May 16, 2013
Days to Decision 45 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 131d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OCX Device Classification - Class 2, Special Controls

Product Code OCX Endoscopic Irrigation/suction System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Supply Sterile Water, Other Solutions And/or Suction To Endoscopes During Endoscopic Procedures.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - OCX Endoscopic Irrigation/suction System

All 73
Devices cleared under the same product code (OCX) and FDA review panel - the closest regulatory comparables to K130909.
TORRENT IRRIGATION SYSTEM
K140405 · United States Endoscopy Group, Inc. · Mar 2014
MEDLINE BIOPSY VALVE
K131426 · Medline Industries, Inc. · Feb 2014
SEAL BIOPSY VALVE - REUSABLE
K132776 · Endochoice, Inc. · Dec 2013
CLEARPATH 24
K112318 · Promedic, Inc. · Jun 2012
BIOPSY VALVE
K111821 · Endochoice, Inc. · Jul 2011
IRRIGATION SYSTEM
K103239 · United States Endoscopy Group, Inc. · Dec 2010