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

    GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER

    K Number: K093904 · Decision Apr 14, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    57
    Applicant Total
    2
    Review Days
    113

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    Basic Information

    Device Name
    GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER
    K Number
    K093904
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Glenveigh Surgical, LLC
    Date Received
    December 22, 2009
    Decision Date
    April 14, 2010
    Product Code
    KNA
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KNA Instrument, Manual, Specialized Obstetric-Gynecologic

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    Other Clearances by Glenveigh Surgical, LLC

    K Number Device Name
    K091958 BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM