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510(k) Data Aggregation

    K Number
    K201098
    Device Name
    Ambu Duodeno System
    Manufacturer
    Ambu Innovation GmbH
    Date Cleared
    2020-07-17

    (84 days)

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

    Ambu Innovation GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The aScope Duodeno is designed to be used with the aBox Duodeno, endoscopic accessories (e.g. biopsy forceps) and other ancillary equipment (e.g. video monitor) for endoscopy and endoscopic surgery within the duodenum. The aBox Duodeno is designed to be used with the aScope Duodeno, endoscopic accessories (e.g. biopsy forceps) and other ancillary equipment (e.g. medical grade video monitor) for endoscopy and endoscopic surgery within the duodenum.
    Device Description
    The Ambu Duodeno System consists of a sterile single-use endoscope, the aScope Duodeno, and a processing unit, the aBox Duodeno. The sterile single use duodenoscope aScope Duodeno consists of a flexible insertion tube with bendable tip, a control body and an umbilicus cord. The insertion tube has a bendable tip which is equipped with a camera to collect image data and a LED light source to illuminate the body cavity. The device contains a working channel through which additional instruments as biopsy devices may be introduced. The aScope Duodeno provides functions for lens washing, insufflation and suction. The aBox Duodeno is an endoscopic video imaging system that receives video signals from the connected endoscope, controls the light at the endoscope tip and outputs this signal including a graphical user interface (GUI) to a connected external video monitor. It also provides signals to capture images by a connected external image capturing system. The aBox Duodeno also contains a peristaltic pump to provide water for the endoscope lens washing function. The peristaltic pump is controlled by the operator via the endoscope.
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