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510(k) Data Aggregation

    K Number
    K960148
    Device Name
    CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENT
    Date Cleared
    1996-03-25

    (74 days)

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

    CABOT MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Surgitek Classic Double Pigtail Ureteral Stent is an indwelling device used to provide drainage from the kidney to the bladder and stenting of the ureter without external catheters. The stent may be placed using endoscopic, percutaneous or open procedures.
    Device Description
    The Circon-Surgitek Classic Double Pigtail Ureteral Stent is a ureteral stent without a hydromer coating. The function of the double pigtail ureteral stent is to provide drainage from the kidney to the bladder and stenting of the ureter without the aid of internal catheters. The Circon-Surgitek Classic Double Pigtail Ureteral Stent has a flexible pigtail curl at both the proximal (kidney) and distal (bladder) end of the stent. The kidney curl of the double pigtail is similar to the Circon-Surgitek Lubri-Flex™ kidney curl [K905289] while the bladder curl is similar to the Circon-Surgitek Multi-Flex [K913928]. These curls minimize upward and downward migration of the device. The curls at each end are formed in opposite directions from each other. The proximal kidney curl hooks, laterally into the lower colon or renal pelvis while the distal bladder curl curves medially into the bladder. The kidney curl, located at the proximal end of the device, is easily distinguished by the open tapered tip (or tail) which extends beyond the curl. The bladder curl, located at the distal end of the device, is distinguished by its open blunt end which does not extend beyond the curl. Drainage holes are located at approximately 2.0 cm intervals in a spiral configuration along the mainshaft of the stent. The Circon-Surgitek Classic Double Pigtail Ureteral Stent is designed for endoscopic or open surgical placement. A medial line is imprinted along the mainshaft of the stent on the side opposite the proximal curl to assist the physician in correctly orienting the curls within the kidney and bladder. The medial line terminates at the axial ring, parallel to the center radius of the distal curl. The axial ring serves as a visual marker to the physician for placement of the stent. The physician advances the stent until the ring is adjacent to the ureterovesical junction. This allows a sufficient amount of the stent to remain in the bladder to fully form the distal curl. A non-absorbable monofilament trailing suture is provided in the distal curl to assist the physician in stent placement and positioning. To protect the suture, a retaining tube is placed over the tapered end of the stent. Other currently marketed components to be packaged with the Circon-Surgitek Classic Double Pigtail Ureteral Stent include: - One (1) Push Catheter .
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