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

    KSEA CLEARVISION II, MODEL 40334120

    K Number: K072410 · Decision May 9, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    90
    Applicant Total
    318
    Review Days
    256

    Basic Information

    Device Name
    KSEA CLEARVISION II, MODEL 40334120
    K Number
    K072410
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1480
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Received
    August 27, 2007
    Decision Date
    May 9, 2008
    Product Code
    GWG
    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
    GWG Endoscope, Neurological

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