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510(k) Data Aggregation

    K Number
    K172299
    Device Name
    Accordion Piccolo Stone Management Device
    Manufacturer
    THS International, Inc. d/b/a Accordion Medical
    Date Cleared
    2017-09-19

    (50 days)

    Product Code
    FFL
    Regulation Number
    876.4680
    Why did this record match?
    Applicant Name (Manufacturer) :

    THS International, Inc. d/b/a Accordion Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Accordion Piccolo Stone Management Device is intended to be used endoscopically to entrap and remove calculi and other foreign objects from the urinary tract and to guide instrumentation within the ureteral tract.
    Device Description
    The Accordion Piccolo's film membrane is attached to a two-part (inner and outer shaft) guidewire and deploys within the lumen of the ureter. The device can be advanced via the working channel of a cystoscope, and advanced under direct vision or fluoroscopy until the tip is proximal to the kidney stone or foreign object. To contain the stone during lithotripsy or entrap a foreign object, the movable core of the guidewire component is advanced by pulling on the handle, which causes the film membrane to deploy within the lumen of the ureter and prevent proximal movement of the stone or object during the surgical procedures. The physician may maintain the film membrane in the deployed position and "sweep" the stone fragments down the ureter and into the bladder or use the deployed film as a "backboard" to prevent migration of the stone fragments into the kidney as he/she removes the fragments with a basket or other device.
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