BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Fluid, Hysteroscopy

    PMA: N17511 · Supplement: S014 · Decision Aug 17, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Fluid, Hysteroscopy
    Trade Name
    HYSKON HYSTEROSCOPY FLUID
    PMA Number
    N17511
    Supplement Number
    S014
    Device Class
    FDA Class 3
    Product Code
    LTA
    Generic Name
    FLUID, HYSTEROSCOPY
    Medical Specialty
    Unknown
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 17, 2001
    Date Received
    March 19, 2001
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF A NEW WATER FOR INJECTION(WFI) GENERATION SYSTEM FOR THE WFI COMPONENT OF THE HYSKON(R) HYSTEROSCOPY FLUID.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LTA Fluid, Hysteroscopy