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

    THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM

    K Number: K083180 · Decision Feb 12, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    111
    Applicant Total
    6
    Review Days
    107

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    Basic Information

    Device Name
    THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
    K Number
    K083180
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Avantis Medical Systems, Inc.
    Date Received
    October 28, 2008
    Decision Date
    February 12, 2009
    Product Code
    FDF
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FDF Colonoscope And Accessories, Flexible/Rigid

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    Other Clearances by Avantis Medical Systems, Inc.

    K Number Device Name
    K160356 Third Eye Panoramic Auxiliary Endoscopy System - Resposable
    K140595 THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY SYSTEM
    K093187 MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
    K091783 THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM
    K070330 THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM