Cleared Traditional

K113310 - ENDOGATER AVANTAGE CO2 INSUFFLATOR

K113310 is an FDA 510(k) clearance for ENDOGATER AVANTAGE CO2 INSUFFLATOR, manufactured by Byrne Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FCX cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K113310 · Byrne Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
225d
Days
Class 2
Risk

K113310 is an FDA 510(k) clearance for the ENDOGATER AVANTAGE CO2 INSUFFLATOR. Classified as Insufflator, Automatic Carbon-dioxide For Endoscope (product code FCX), Class II - Special Controls.

Submitted by Byrne Medical, Inc. (Minneapolis, US). The FDA issued a Cleared decision on June 20, 2012 after a review of 225 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 - K113310

510(k) Number K113310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2011
Decision Date June 20, 2012
Days to Decision 225 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
95d slower than avg
Panel avg: 130d · This submission: 225d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FCX Device Classification - Class 2, Special Controls

Product Code FCX Insufflator, Automatic Carbon-dioxide For Endoscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 - FCX Insufflator, Automatic Carbon-dioxide For Endoscope

All 15
Devices cleared under the same product code (FCX) and FDA review panel - the closest regulatory comparables to K113310.
BAROnova Insufflation System, BAROnova Accessory Kit
K190985 · Baronova, Inc. · May 2019
FUJIFILM Endoscopic CO2 Regulator GW-100
K180711 · Fujifilm Corporation · May 2018
FUJIFILM ENDOSCOPIC CO2 REGULATOR
K133976 · Fujifilm Medical System U.S.A., Inc. · Sep 2014
ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2
K063786 · Olympus Medical Systems Corporation · Mar 2007
E-Z-EM ENDOSCOPIC CO2 REGULATOR
K053008 · E-Z-Em, Inc. · Dec 2005
PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400
K030854 · E-Z-Em, Inc. · Apr 2003