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    K Number
    DEN240018
    Device Name
    CORIS System
    Manufacturer
    Nanosonics Limited
    Date Cleared
    2025-03-19

    (322 days)

    Product Code
    FEB
    Regulation Number
    876.1500
    Type
    Direct
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Nanosonics CORIS System is indicated for cleaning of the channels of the Olympus EVIS EXERA III CF-HQ190L colonovideoscope.

    The CORIS System is suitable for use in healthcare facilities by trained healthcare workers.

    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 System is intended to replace manual cleaning of the channels of Olympus EVIS EXERA III CFHQ190L colonovideoscope (CF-HQ190L) (primary DI number 04953170305115), with an automated cleaning cycle. 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.

    All external surfaces of the endoscope must still be cleaned and reprocessed according to the endoscope manufacturer's instructions. An endoscope that has had internal channels cleaned by the CORIS System must be high-level disinfected using an accelerated hydrogen peroxide-based solution, for example, Revital-Ox® RESERT® High Level Disinfectant.

    The CORIS System is intended to be used in healthcare settings within reprocessing areas where endoscopes are cleaned, such as endoscope reprocessing departments and central sterile processing departments. The device is intended to be installed and used at the sink in the decontamination area of these departments.

    The CORIS System consists of the CORIS Device and its accessories. CORIS accessories are not supplied with the CORIS Device and must be purchased separately, except the following components: 1) CORIS Splash Guard and 2) non-medical device components required during initial set up and installation only including the CORIS Splash Guard Drain Tube, CORIS Drain Spigot Adaptor, Air Supply Tube, Water Supply Tube, Power Supply Unit and Regional Mains Connector, CORIS Splash Guard Mounting Kit, CORIS Lifting Accessory, CORIS Wall Mount Fastening Kit, and CORIS Wall Mount.

    AI/ML Overview

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