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510(k) Data Aggregation

    K Number
    K021602
    Device Name
    FOSSA URETERAL STONE SWEEPER
    Date Cleared
    2002-07-26

    (72 days)

    Product Code
    Regulation Number
    876.4620
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOSSA INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Fossa Ureteral Stone Sweeper is indicated for use as an indwelling ureteral catheter to promote drainage of urine from the kidney to the bladder, and/or for the manipulation, capture and removal of urinary calculi.
    Device Description
    The Fossa Ureteral Stone Sweeper set consists of a flexible, Piqtail tipped, selfexpanding stent with: Insertion sheath, "Pusher," and optional pre-attached suture to facilitate stent removal. The stent is offered in various diameters and working lengths. Short slits along the working length of the stent allow radial device expansion to permit fluid flow through and around the device, and to permit stone passage into the inner stent's lumen.
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    K Number
    K021140
    Device Name
    FOSSA EXPANDING DOUBLE PIGTAIL URETERAL STENT
    Date Cleared
    2002-06-28

    (80 days)

    Product Code
    Regulation Number
    876.4620
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOSSA INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Fossa Double Pigtail Expanding Ureteral Stent is indicated for use as an indwelling ureteral catheter for drainage of urine from the kidney to the bladder.
    Device Description
    The Fossa Expanding Double Pigtail Ureteral Stent set consists of a flexible, Pigtail tipped, self-expanding stent with: Insertion sheath, "Pusher," and optional pre-attached suture to facilitate stent removal. The stent is offered in various diameters and working lengths. Short slits along the working length of the stent allow radial device expansion to permit fluid flow through and around the device.
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