BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    CORIS System

    K Number: K253267 · Decision Mar 5, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    6
    Review Days
    157

    Basic Information

    Device Name
    CORIS System
    K Number
    K253267
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6994
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nanosonics Limited
    Date Received
    September 29, 2025
    Decision Date
    March 5, 2026
    Product Code
    SEW
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SEW Automated Endoscope Channel Cleaner

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