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

    ANSPACH MICROMAX SYSTEM

    K Number: K965080 · Decision Jan 10, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    90
    Applicant Total
    60
    Review Days
    22

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    Basic Information

    Device Name
    ANSPACH MICROMAX SYSTEM
    K Number
    K965080
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4250
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    The Anspach Effort, Inc.
    Date Received
    December 19, 1996
    Decision Date
    January 10, 1997
    Product Code
    ERL
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

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    Other Clearances by The Anspach Effort, Inc.

    K Number Device Name
    K220485 Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)
    K183545 Anspach Helix Dissection Tools
    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
    Search all 60 clearances from The Anspach Effort, Inc. →