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

    TIPCAM 1S 3D System

    K Number: K162880 · Decision Mar 16, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    92
    Applicant Total
    25
    Review Days
    153

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    Basic Information

    Device Name
    TIPCAM 1S 3D System
    K Number
    K162880
    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
    October 14, 2016
    Decision Date
    March 16, 2017
    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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