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

    ACRA-CUT

    K Number: K833266 · Decision Dec 29, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    17
    Applicant Total
    8
    Review Days
    99

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    Basic Information

    Device Name
    ACRA-CUT
    K Number
    K833266
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4305
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Acra Cut, Inc.
    Date Received
    September 21, 1983
    Decision Date
    December 29, 1983
    Product Code
    HBF
    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
    HBF Drills, Burrs, Trephines & Accessories (Compound, Powered)

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    Other Clearances by Acra Cut, Inc.

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    K032970 ACRA-CUT XPRESS 120
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    K911819 ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED
    K911812 ACRA-CUT WIRE PASS DRILL
    K910225 BONE PAD REMOVER
    K910226 DURAL DISSECTORS
    K892866 AUTOMATIC CRANIAL DRILL (PERFORATOR)