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510(k) Data Aggregation

    K Number
    K962246
    Device Name
    RIGID FIBER OPTIC LAPAROSCOPE
    Date Cleared
    1997-02-07

    (241 days)

    Product Code
    Regulation Number
    884.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEALTH CARE INTERNATIONAL ASSOC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Saber's Rigid Fiber Optic Laparoscopes are used to permit direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures.
    Device Description
    Saber Endoscopy's Rigid Fiber Optic Laparoscopes are small diameter endoscopes which consist of fiber optic imaging fibers and illumination fibers contained within a stainless steel jacket. Light from a high intensity light source is transmitted to the scope by a detachable light carrying cable. The light is then carried by the illumination fibers to the target. A distal lens focuses an image of the target onto the image fiber bundle. The image is transmitted to the proximal end of the scope, where it is magnified and focused by an optical eyepiece. The image may be viewed directly through the eyepiece, or the scope may be connected to a video system via a standard endoscopic video coupler.
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