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510(k) Data Aggregation

    K Number
    K160077
    Device Name
    RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set
    Date Cleared
    2016-07-12

    (180 days)

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

    JBW7 Innovations, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Used to gain precise percutaneous access to the kidney by means of controlled fine wire puncture from within the collecting system. This set and suggested procedure are particularly well-suited for gaining percutaneous access to an unobstructed, non-dilated collecting system when pursuing a planned course of endourological intervention. Fluoroscopic control is necessary throughout this procedure. Intended for one-time use.
    Device Description
    The RetroPerc™ Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set is used to gain precise percutaneous access to the kidney by means of controlled fine wire puncture from within the collecting system. The RetroPerc™ Wire Puncture Set consists of a puncture wire, tip protector sheath with mounted pin-vise actuator, radiopaque exchange catheter, and fascial dilators. A stainless steel puncture wire is advanced within a protective sheath via the working channel of a flexible ureteroscope positioned in the targeted calyx, at which time the puncture wire is advanced through the kidney, perirenal tissue and fascia, until it emerges at the patient's flank skin. An exchange catheter (coaxial catheter in CX set or single lumen catheter in the LX set) is then positioned over the puncture wire at the flank, after which the puncture wire is removed. A standard 0.038 inch wire guide is then advanced through the exchange catheter until it advances out of the urethra. The exchange catheter is then removed, and finally the tract is dilated with fascial dilators, as clinically indicated. The RetroPerc Wire Puncture Set will be available in two configurations: CX and LX. Each set will perform well for the same patient populations and kidney stones, has the same indications, etc. The choice of set will be driven by physician preference: the CX set if the surgeon wishes to use a coaxial exchange catheter, and the LX set if the surgeon wishes to use non-coaxial exchange catheter.
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