Cleared Traditional

K133976 - FUJIFILM ENDOSCOPIC CO2 REGULATOR (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K133976 · Fujifilm Medical System U.S.A., Inc. · Gastroenterology & Urology device
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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

Submission Details

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
Regulatory Context
Review time vs. panel average
127d slower than avg
Panel avg: 130d · This submission: 257d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.