Not Cleared Direct

DEN240018 - CORIS System (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN240018 · Nanosonics Limited · General Hospital
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Mar 2025
Decision
322d
Days
Class 2
Risk

DEN240018 is an FDA 510(k) submission (not cleared) for the CORIS System. Classified as Automated Endoscope Channel Cleaner (product code SEW), Class II - Special Controls.

Submitted by Nanosonics Limited (Macquarie Park, AU). The FDA issued a Not Cleared (DENG) decision on March 19, 2025 after a review of 322 days.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6994 - the FDA general hospital device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 322 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

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Submission Details

510(k) Number DEN240018 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received May 01, 2024
Decision Date March 19, 2025
Days to Decision 322 days
Submission Type Direct
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
194d slower than avg
Panel avg: 128d · This submission: 322d
Pathway characteristics

Device Classification

Product Code SEW Automated Endoscope Channel Cleaner
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6994
Definition An Automated Endoscope Channel Cleaner Is A Device Intended To Replace All Or A Portion Of Manual Cleaning Of Internal Passages And Ports Of Compatible Reusable Flexible Endoscopes. Cleaning Is Conducted Using An Agent That Exerts Physical Force (e.g., Friction) On Single Or Multiple Channels Of Compatible Endoscopes For Removal Of Soil. This Device Type Is Not Intended To Provide Or Replace High-level Disinfection Or Sterilization.
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 General Hospital devices follow this clearance model.