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

    CRANIOTOME BLADE OR NEURO BLADE

    K Number: K881418 · Decision May 31, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    64
    Applicant Total
    3
    Review Days
    57

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    Basic Information

    Device Name
    CRANIOTOME BLADE OR NEURO BLADE
    K Number
    K881418
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4310
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Nuell Air Equipment & Hospital Supplies, Inc.
    Date Received
    April 4, 1988
    Decision Date
    May 31, 1988
    Product Code
    HBE
    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
    HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)

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    Other Clearances by Nuell Air Equipment & Hospital Supplies, Inc.

    K Number Device Name
    K880601 WIRE PASS DRILL BITS
    K880706 SURGICAL BURS