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510(k) Data Aggregation

    K Number
    K092584
    Device Name
    LAPORT
    Manufacturer
    MGB ENDOSKOPISCHE GERATE GMBH (BERLIN)
    Date Cleared
    2010-03-22

    (210 days)

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

    MGB ENDOSKOPISCHE GERATE GMBH (BERLIN)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MGB LAPORT sterile Trocars for Endoscopic surgery are intended to establish a path of entry for endoscopic abdominal, for use during general, instruments gynaecological and thoracic minimally invasive procedures or to gain access through tissue planes and/or potential spaces for endoscopic instruments.
    Device Description
    Not Found
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    K Number
    K093194
    Device Name
    MGB DISPOSABLE RETRIEVAL BAG LAPBAG
    Manufacturer
    MGB ENDOSKOPISCHE GERATE GMBH (BERLIN)
    Date Cleared
    2010-03-03

    (145 days)

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

    MGB ENDOSKOPISCHE GERATE GMBH (BERLIN)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MGB LAPBAG sterile retrieval bag for Endoscopic surgery is intended to be used for: - -General surgery - Abdominal surgery - . - Gynecological surgery - - Thoracic minimally invasive procedures. - The Specimen Retrieval Bag is indicated for use in endoscopic procedures to allow tissues or debris to be removed from the abdominal cavity.
    Device Description
    Not Found
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    K Number
    K032544
    Device Name
    VP-1000; MED CAM 100; VP-3000A; MED CAM 300
    Manufacturer
    MGB ENDOSKOPISCHE GERATE GMBH (BERLIN)
    Date Cleared
    2003-09-02

    (15 days)

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

    MGB ENDOSKOPISCHE GERATE GMBH (BERLIN)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Endoscopic cameras VP-1000C ( Med Cam 100) and VP-3000A /Med Cam 300) are intended to attach to standard endoscopes to permit visualization of body cavities, hollow organs and canals during endoscopic procedures. It also may be attached to a microscope. The endoscopic image can be displayed on any standard video monitor.
    Device Description
    The Endoscopic camera VP-1000C ( Med Cam 100) is a 1-CCD camera, the VP-3000A (Med Cam 300) is a 3-Chip camera; both consist of a camera control unit (CCU), a camera head, various connecting objectives, cables and adapters. The Endoscopic cameras VP-1000C (Med Cam 100) and VP-3000A (Med Cam 300) take the image through standard endoscopes that would be normally seen with the naked eye, and displays it on any standard video monitor. The camera heads are supplied with an standard objective with the focal length 18, 25, 30 or 40mm. A Zoom objective can be used too. The devices allow focussing for both right-handed and left-handed users.
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    K Number
    K032545
    Device Name
    ENDOSCOPIC LIGHT SOURCE LS-3000X; LS-1800XG/MED LIGHT X 180; LS-2500H/MED LIGHT H 250
    Manufacturer
    MGB ENDOSKOPISCHE GERATE GMBH (BERLIN)
    Date Cleared
    2003-09-02

    (15 days)

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

    MGB ENDOSKOPISCHE GERATE GMBH (BERLIN)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Light Sources LS-1800XG (Med Light X180), LS-3000X, LS-2500H (Med Light H250) provide illumination for fiberoptic endoscopy to gastroenterological and urological cavities, hollow organs and canals.
    Device Description
    The Endoscopic Light Source LS-300X uses a 300W xenon lamp to provides illumination during endoscopic diagnostic and surgical procedures through a fiber optic cable, which is connected to the device. Brightness can be adjusted manually. The color temperature is approximately 5600°K and the lamp life is approximately 500 hours. The Endoscopic Light Source LS-1800X (Med Light X 180) uses a 180W xenon lamp to provides illumination during endoscopic diagnostic and surgical procedures through a fiber optic cable, which is connected to the device. Brightness can be adjusted manually. The color temperature is approximately 6000°K and the lamp life is approximately 500 hours. The Endoscopic Light Source LS-2500H (Med Light H 250) uses two 250W halogen lamps to provides illumination during endoscopic diagnostic and surgical procedures through a fiber optic cable, which is connected to the device. Brightness can be adjusted manually. The color temperature is approximately 3400°K and the lamp life is approximately 50 hours.
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