Cleared Special

K240352 - Defendo Single Use Cleaning Adapter for...

K240352 is the FDA 510(k) clearance for Defendo Single Use Cleaning Adapter for... by STERIS Corporation. It is a Class 2 Gastroenterology & Urology device (product code ODC) cleared through the Special 510(k) pathway after a 30-day FDA review.

K240352 · STERIS Corporation · Gastroenterology & Urology device
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Mar 2024
Decision
30d
Days
Class 2
Risk

K240352 is an FDA 510(k) clearance for the Defendo Single Use Cleaning Adapter for Olympus Endoscopes. 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 March 6, 2024 after a review of 30 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 K240352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2024
Decision Date March 06, 2024
Days to Decision 30 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
100d faster than avg
Panel avg: 130d · This submission: 30d
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 K240352.
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
K232067 · Medivators (A Subsidiary of Steris Corporation) · Mar 2024
Endorail
K232327 · Endostart S.R.L. · Mar 2024
Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector
K232004 · Medivators (A Subsidiary of Steris Corporation) · Mar 2024
DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
K240098 · STERIS Corporation · Feb 2024
Defendo Fujifilm 700 Single Use Biopsy Valve
K232329 · Medivators (A Subsidiary of Steris Corporation) · Dec 2023
PENTAX Medical Gas/Water Feeding Valve OE-B14
K232249 · Pentax of America, Inc. · Dec 2023