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510(k) Data Aggregation

    K Number
    K123438
    Device Name
    XENX STONE MANAGEMENT DEVICE
    Manufacturer
    Date Cleared
    2013-01-10

    (63 days)

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

    XENOLITH MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The XenX device is intended to be used endoscopically to bypass and entrap calculi from the urinary tract, to prevent retrograde migration of calculi during laser lithotripsy and to facilitate the placement of endourological instruments during diagnostic or interventional procedures.
    Device Description
    Not Found
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    K Number
    K113692
    Device Name
    XENX
    Manufacturer
    Date Cleared
    2012-08-09

    (238 days)

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

    XENOLITH MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The XenX device is intended to be used endoscopically to bypass and entrap calculi from the urinary tract, to prevent retrograde migration of calculi during laser lithotripsy,and to facilitate the placement of endourological instruments during diagnostic or interventional procedures
    Device Description
    The XenX device combines several features in one device which facilitate an endoscopic procedure. The XenX easily tracks past ureteral kidney stone and is navigated under fluoroscopy like a urologic guidewire. Once in place, a self expandable braided structure is deployed to block the ureteral lumen and prevent stone particle migration towards the kidney. The braided structure enables a constant irrigation flow for clear uretroscopic vision during the procedure. Following stone fragmentation and if required the physician can choose to propagate a urinary stent over the device for ureteral placement.
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