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

    Monarch Bronchoscope

    K Number: K231473 · Decision Nov 28, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    190

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    Basic Information

    Device Name
    Monarch Bronchoscope
    K Number
    K231473
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Auris Health, Inc., A Johnson and Johnson Family Company
    Date Received
    May 22, 2023
    Decision Date
    November 28, 2023
    Product Code
    QNW
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QNW Reprocessed Bronchoscope

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QNW), ordered by most recent decision date.

    Monarch Bronchoscope

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat
    View all

    Other Clearances by Auris Health, Inc., A Johnson and Johnson Family Company

    K Number Device Name
    K203614 Monarch Bronchoscope