BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    THE IMMOBILIZER FOR OPEN & ARTHROSCOPIC

    K Number: K802271 · Decision Oct 23, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    19
    Applicant Total
    60
    Review Days
    36

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    Basic Information

    Device Name
    THE IMMOBILIZER FOR OPEN & ARTHROSCOPIC
    K Number
    K802271
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4950
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    The Anspach Effort, Inc.
    Date Received
    September 17, 1980
    Decision Date
    October 23, 1980
    Product Code
    BWN
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BWN Table And Attachments, Operating-Room

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    Other Clearances by The Anspach Effort, Inc.

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    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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