Cleared Special

K240098 - DEFENDO Single Use Valve Kit AW/S Valve...

K240098 is the FDA 510(k) clearance for DEFENDO Single Use Valve Kit AW/S Valve... by STERIS Corporation. It is a Class 2 Gastroenterology & Urology device (product code ODC) cleared through the Special 510(k) pathway after a 28-day FDA review.

K240098 · STERIS Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
28d
Days
Class 2
Risk

K240098 is an FDA 510(k) clearance for the DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900). Classified as Endoscope Channel Accessory (product code ODC), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on February 9, 2024 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all STERIS Corporation devices

Submission Details

510(k) Number K240098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2024
Decision Date February 09, 2024
Days to Decision 28 days
Submission Type Special
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
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 49
Devices cleared under the same product code (ODC) and FDA review panel - the closest regulatory comparables to K240098.
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K232244 · Changzhou Endoclean Medical Device Co., Ltd. · Nov 2023