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510(k) Data Aggregation

    K Number
    K063654
    Device Name
    ENDOGUIDE
    Manufacturer
    KMS MEDICAL LLC
    Date Cleared
    2007-01-31

    (54 days)

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

    KMS MEDICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EndoGuide is intended to be used with an endoscope to facilitate intubation, change of endoscopes, and removal of multiple polyps and/or foreign bodies.
    Device Description
    The EndoGuide fits over a pediatric colonoscope and can be converted from a flexible to a rigid configuration on demand. The EndoGuide is back loaded onto the shaft of the colonoscope before the instrument is inserted into the patient. The device was designed to be activated by a vacuum source and needs to be connected to the existing vacuum line in the endoscopy suite. Application of vacuum causes the device to become rigid. In this "active" mode (vacuum on) the rigid insertion tube facilitates the passing of the colonoscope thru the insertion tube and resists colonoscope looping. In the "passive" mode (vacuum off) the insertion tube is very flexible and can be advanced deeper into the colon.
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