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

    ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED

    K Number: K911819 · Decision Sep 10, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    64
    Applicant Total
    8
    Review Days
    139

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    Basic Information

    Device Name
    ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED
    K Number
    K911819
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4310
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Acra Cut, Inc.
    Date Received
    April 24, 1991
    Decision Date
    September 10, 1991
    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 Acra Cut, Inc.

    K Number Device Name
    K032970 ACRA-CUT XPRESS 120
    K944311 ACRA-CUT
    K911812 ACRA-CUT WIRE PASS DRILL
    K910225 BONE PAD REMOVER
    K910226 DURAL DISSECTORS
    K892866 AUTOMATIC CRANIAL DRILL (PERFORATOR)
    K833266 ACRA-CUT