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510(k) Data Aggregation

    K Number
    K964131
    Device Name
    ENDOSCOPE
    Manufacturer
    AKOS BIOMEDICAL, INC.
    Date Cleared
    1997-06-27

    (255 days)

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

    AKOS BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The endoscope system is used to examine body cavities, hollow organs and canals, specifically the lower GI tract (colon) only, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
    Device Description
    The endoscope system includes the endoscope with control head, a disposable assembly, an imaging system, and a fluid and air system. The endoscope system features: 1) a smooth control head containing a minimal number of outside angles and joint crevices, 2) a single use disposable system encompassing all of the inner passage channels that start at the manifold, continue through the endoscope cavity, and seal onto the outside of the rigid distal tip, 3) a pneumatically driven air and fluid system eliminating the need for mechanical valves in the contamination path, and 4) a lavage function that provides a bolus of water through the working channel to loosen and flush debris from the field of view as the insertion tube advances through the colon.
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