Cleared Traditional

K113119 - ENDOGATOR ADVANTAGE IRRIGATION PUMP

K113119 is an FDA 510(k) clearance for ENDOGATOR ADVANTAGE IRRIGATION PUMP, manufactured by Byrne Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCX cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K113119 · Byrne Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
189d
Days
Class 2
Risk

K113119 is an FDA 510(k) clearance for the ENDOGATOR ADVANTAGE IRRIGATION PUMP. Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by Byrne Medical, Inc. (Minneapolis, US). The FDA issued a Cleared decision on April 27, 2012 after a review of 189 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Byrne Medical, Inc. devices

FDA 510(k) Submission Details - K113119

510(k) Number K113119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2011
Decision Date April 27, 2012
Days to Decision 189 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 130d · This submission: 189d
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 66
Devices cleared under the same product code (OCX) and FDA review panel - the closest regulatory comparables to K113119.
MEDLINE BIOPSY VALVE
K131426 · Medline Industries, Inc. · Feb 2014
SEAL BIOPSY VALVE - REUSABLE
K132776 · Endochoice, Inc. · Dec 2013
GATEWAY ADVANAGE Y-ADAPTER
K130909 · Boston Scientific Corp · May 2013
BIOPSY VALVE
K111821 · Endochoice, Inc. · Jul 2011
IRRIGATION SYSTEM
K103239 · United States Endoscopy Group, Inc. · Dec 2010
ERBEFLO 2 DISPOSABLE TUBING SYSTEM
K103235 · Erbe USA, Inc. · Dec 2010