BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Monarch Platform, Urology

    K Number: K213334 · Decision Apr 29, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    120
    Registration Numbers
    120
    Same Product Code
    112
    Applicant Total
    4
    Review Days
    205

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    Basic Information

    Device Name
    Monarch Platform, Urology
    K Number
    K213334
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Auris Health, Inc.
    Date Received
    October 6, 2021
    Decision Date
    April 29, 2022
    Product Code
    FGB
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FGB Ureteroscope And Accessories, Flexible/Rigid

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    Other Clearances by Auris Health, Inc.

    K Number Device Name
    K243219 MONARCH™ Platform (MON-000008)
    K211493 Monarch Platform
    K193534 Monarch Platform