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510(k) Data Aggregation

    K Number
    K232327
    Device Name
    Endorail
    Manufacturer
    Endostart s.r.l.
    Date Cleared
    2024-03-15

    (225 days)

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

    Endostart s.r.l.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ENDORAIL is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope (i.e. an endoscope with an instrument channel that is at least 3.7mm diameter and is used for standard endoscopic visualization) during endoscopy of the large intestine.
    Device Description
    ENDORAIL is a colonoscopy add-on device developed to be used without any modification to colonoscopes and peripheral devices currently utilized. It is an accessory for colonoscopy aimed at facilitating progression of the endoscope in the large intestine. The device works as a magnetic anchor that allows the operator to guide the colonoscope and to straighten colon curves and loops. ENDORAIL includes a Balloon Guide that can be introduced, when needed, through the endoscope instrument channel during the colonoscopy, if this procedure becomes challenging. The system does not require to be premounted and does not interfere with the normal colon examination process. The Balloon Guide is advanced beyond the colonoscope tip where the balloon is filled with a ferromagnetic fluid and magnetically anchored to a magnetic Handpiece placed on the patient's abdomen. Once anchored, the colonoscope can be easily straightened and guided along the device, allowing a fast and safe inspection of the entire colon. Once the challenging segment of the colon is resolved, or the colonoscopy procedure is completed, the Balloon Guide can be retrieved.
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