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510(k) Data Aggregation

    K Number
    K253267

    Validate with FDA (Live)

    Device Name
    CORIS System
    Manufacturer
    Nanosonics Limited
    Date Cleared
    2026-03-05

    (157 days)

    Product Code
    SEW
    Regulation Number
    880.6994
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Nanosonics CORIS System is indicated for cleaning of the channels of compatible endoscopes.
    The CORIS System is suitable for use in healthcare facilities by trained healthcare personnel.

    Device Description

    The CORIS System is an automated electromechanical device which utilizes the CORIS QUANTUM Cleaning Agent to clean endoscope channels (including interior of the lumens, ports, and cylinders) of validated and compatible reusable flexible endoscopes. The CORIS QUANTUM Cleaning Agent is provided as a dry powder, which upon installation is hydrated to create a slurry. During the cleaning cycle, the CORIS System delivers the cleaning agent providing physical cleaning to all endoscope channels. The endoscope channels are then rinsed and purged with air. The CORIS System is intended for over-the-counter use by healthcare personnel.

    AI/ML Overview

    N/A

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