Cleared Traditional

K232067 - Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector (FDA 510(k) Clearance)

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

K232067 · Medivators (A Subsidiary of Steris Corporation) · Gastroenterology & Urology device
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Mar 2024
Decision
255d
Days
Class 2
Risk

K232067 is an FDA 510(k) clearance for the Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600.... Classified as Endoscope Channel Accessory (product code ODC), Class II - Special Controls.

Submitted by Medivators (A Subsidiary of Steris Corporation) (Conroe, US). The FDA issued a Cleared decision on March 22, 2024 after a review of 255 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 Medivators (A Subsidiary of Steris Corporation) devices

Submission Details

510(k) Number K232067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2023
Decision Date March 22, 2024
Days to Decision 255 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
125d slower than avg
Panel avg: 130d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODC Endoscope Channel Accessory
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Give The Endoscope Channel Additional Or Improved Functionality.
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 - ODC Endoscope Channel Accessory

All 70
Devices cleared under the same product code (ODC) and FDA review panel - the closest regulatory comparables to K232067.
Biopsy Port Adapter
K250145 · Endosound, Inc. · Oct 2025
Orca Air/Water and Suction Valves
K252910 · Boston Scientific · Oct 2025
Suction Valve (MAJ-1443)
K250949 · Olympus Medical Systems Corporation · Jul 2025
Disposable Endoscopy Valve Set
K250732 · Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Jun 2025
Luer-Split MAJ-2092
K241842 · Olympus Medical Systems Corporation · Mar 2025
Defendo Fujifilm 700 Single Use Cleaning Adapter
K250140 · Steris Corparation · Feb 2025