Cleared Traditional

K133976 - FUJIFILM ENDOSCOPIC CO2 REGULATOR

K133976 is an FDA 510(k) clearance for FUJIFILM ENDOSCOPIC CO2 REGULATOR, manufactured by Fujifilm Medical System U.S.A., Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FCX cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K133976 · Fujifilm Medical System U.S.A., Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Sep 2014
Decision
257d
Days
Class 2
Risk

K133976 is an FDA 510(k) clearance for the FUJIFILM ENDOSCOPIC CO2 REGULATOR. Classified as Insufflator, Automatic Carbon-dioxide For Endoscope (product code FCX), Class II - Special Controls.

Submitted by Fujifilm Medical System U.S.A., Inc. (Wayne, US). The FDA issued a Cleared decision on September 9, 2014 after a review of 257 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 Fujifilm Medical System U.S.A., Inc. devices

FDA 510(k) Submission Details - K133976

510(k) Number K133976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2013
Decision Date September 09, 2014
Days to Decision 257 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
126d slower than avg
Panel avg: 131d · This submission: 257d
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 20
Devices cleared under the same product code (FCX) and FDA review panel - the closest regulatory comparables to K133976.
BAROnova Insufflation System, BAROnova Accessory Kit
K190985 · Baronova, Inc. · May 2019
FUJIFILM Endoscopic CO2 Regulator GW-100
K180711 · Fujifilm Corporation · May 2018
Nexcore GI Insufflator
K162332 · Nexcore Technology, LLC · Sep 2016
BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR
K132192 · Bracco Diagnostic, Inc. · Feb 2014
BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET
K123047 · Bracco Diagnostic, Inc. · Aug 2013
ENDOGATER AVANTAGE CO2 INSUFFLATOR
K113310 · Byrne Medical, Inc. · Jun 2012