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

    NEURO CUSTOM SURGICAL KIT

    K Number: K844594 · Decision Jun 13, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    23
    Applicant Total
    9
    Review Days
    199

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    Basic Information

    Device Name
    NEURO CUSTOM SURGICAL KIT
    K Number
    K844594
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4700
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Xanmed Corp.
    Date Received
    November 26, 1984
    Decision Date
    June 13, 1985
    Product Code
    HBA
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HBA Neurosurgical Paddie

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    Other Clearances by Xanmed Corp.

    K Number Device Name
    K864623 OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT
    K844595 ORTHOPEDIC CUSTOM SURGICAL KIT
    K844596 EMERGENCY ROOM & MINOR OFFICE PROCEDURE CUSTOM KIT
    K844593 CARDIOVASCULAR CUSTOM SURGICAL KIT
    K851906 SURGICAL EYE PACK
    K844597 MISCELLANEOUS GENERAL SURGICAL CUSTOM KIT
    K843642 SUBCLAVIAN LEAD INTRODUCER SYS
    K843641 CATHETER INTRODUCER SYSTEM