BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    invendoscopy E200 System

    K Number: K161355 · Decision Aug 25, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    111
    Applicant Total
    2
    Review Days
    101

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    Basic Information

    Device Name
    invendoscopy E200 System
    K Number
    K161355
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Invendo Medical GmbH
    Date Received
    May 16, 2016
    Decision Date
    August 25, 2016
    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 Invendo Medical GmbH

    K Number Device Name
    K173085 invendoscopy E210 System