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510(k) Data Aggregation

    K Number
    K173085
    Device Name
    invendoscopy E210 System
    Manufacturer
    invendo medical GmbH
    Date Cleared
    2018-01-08

    (101 days)

    Product Code
    FDF
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    invendo medical GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The invendoscopy E210 System is intended to provide visualization and diagnostic / therapeutic access to the adult lower gastrointestinal tract (including but not limited to, the anus, rectum, sigmoid colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery. The colonoscope component of the invendoscopy E210 System, the invendoscope SC210, is a sterile single use disposable device. The invendoscope SC210 cannot be reprocessed.
    Device Description
    The invendoscopy E210 System consists of an invendoscope SC210, an invendo E210 Processing Unit, an invendo E210 Power Unit, an invendo ScopeController and an invendo Drying Adapter. The invendo E210 Processing Unit and the invendo E210 Power Unit together form the invendo SPU E210. The invendoscope SC210 is a sterile single-use disposable colonoscope. The distal tip of the colonoscope is deflectable and equipped with a CMOS camera and LEDs for illumination. A working channel is incorporated for biopsies and polypectomies. The invendoscope SC210 is furthermore equipped with insufflation, irrigation and suction functions. The invendo E210 SPU (consisting of invendo E210 Processing Unit and invendo E210 Power Unit) contains the video signal processing technology which enables the endoscope to illuminate, view, record and transmit video data of endoscopic images. The invendo SPU E210 supplies the colonoscope and controls its functions according to the commands of the operator. The operator uses the invendo ScopeController unit to control the invendoscopy E210 System. The invendo ScopeController allows the operator to control following functions of the colonoscope: deflection of the tip; insufflation; irrigation and suction. The invendo ScopeController also allows the user to record images. The invendo Drying Adapter is intended to support drying of the inner parts of the invendo SPU E210. It is used to connect a waste container to the invendo SPU E210.
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    K Number
    K161355
    Device Name
    invendoscopy E200 System
    Manufacturer
    Invendo Medical GmbH
    Date Cleared
    2016-08-25

    (101 days)

    Product Code
    FDF
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Invendo Medical GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The invendoscopy E200 System is intended to provide visualization and diagnostic / therapeutic access to the adult lower gastrointestinal tract (including but not limited to, the anus, rectum, sigmoid colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery. The colonoscope component of the invendoscopy E200 System, the invendoscope SC200, is a sterile single use disposable device. The invendoscope SC200 cannot be reprocessed.
    Device Description
    The invendoscopy E200 System consists of an invendoscope SC200, an invendo SPU E200, an invendo ScopeController and an invendo E200 Drying Adapter. The invendoscope SC200 is a sterile single-use disposable colonoscope. The distal tip of the colonoscope is deflectable and equipped with a CMOS camera and LEDs for illumination. A working channel is incorporated for biopsies and polypectomies. The invendoscope SC200 is furthermore equipped with insufflation, irrigation and suction functions. The invendo SPU E200 contains the video signal processing technology which enables the endoscope to illuminate, view, record and transmit video data of endoscopic images. The invendo SPU E200 supplies the colonoscope and controls its functions according to the commands of the operator. The operator uses the invendo ScopeController unit to control the invendoscopy E200 System. The invendo ScopeController allows the operator to control following functions of the colonoscope: deflection of the tip; insufflation; irrigation and suction. The invendo ScopeController also allows the user to record images. The invendo E200 Drying Adapter is intended to support drying of the inner parts of the invendo SPU E200. It is used to connect a waste container to the invendo SPU E200.
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