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

    STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000

    K Number: K100852 · Decision May 6, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    41

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    Basic Information

    Device Name
    STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000
    K Number
    K100852
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Communications
    Date Received
    March 26, 2010
    Decision Date
    May 6, 2010
    Product Code
    OCS
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    OCS Endoscopic Video Imaging System/Component, Gastroenterology-Urology

    Other Clearances by Stryker Communications

    K Number Device Name
    K132747 VISUM BLADE LED SURGICAL LIGHTING SYSTEM