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

    ANSPACH EMAX DRILL SYSTEM

    K Number: K011444 · Decision Aug 8, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    25
    Applicant Total
    60
    Review Days
    89

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    Basic Information

    Device Name
    ANSPACH EMAX DRILL SYSTEM
    K Number
    K011444
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4360
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Anspach Effort, Inc.
    Date Received
    May 11, 2001
    Decision Date
    August 8, 2001
    Product Code
    HBC
    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
    HBC Motor, Drill, Electric

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    Other Clearances by The Anspach Effort, Inc.

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    K180063 OCM-G1 Attachment
    K133604 ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS
    K131053 ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM
    K113476 ANSPACH DISSECTION TOOLS
    K082637 CRANIAL PERFORATOR
    K080802 EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL
    K061297 ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM
    K063688 SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE
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