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

    OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT

    K Number: K864623 · Decision Jan 14, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    57
    Applicant Total
    9
    Review Days
    50

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    Basic Information

    Device Name
    OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT
    K Number
    K864623
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Xanmed Corp.
    Date Received
    November 25, 1986
    Decision Date
    January 14, 1987
    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 Xanmed Corp.

    K Number Device Name
    K844595 ORTHOPEDIC CUSTOM SURGICAL KIT
    K844596 EMERGENCY ROOM & MINOR OFFICE PROCEDURE CUSTOM KIT
    K844593 CARDIOVASCULAR CUSTOM SURGICAL KIT
    K844594 NEURO CUSTOM SURGICAL KIT
    K851906 SURGICAL EYE PACK
    K844597 MISCELLANEOUS GENERAL SURGICAL CUSTOM KIT
    K843642 SUBCLAVIAN LEAD INTRODUCER SYS
    K843641 CATHETER INTRODUCER SYSTEM