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510(k) Data Aggregation

    K Number
    K082919
    Device Name
    UC-CARE POSITIONING SYSTEM
    Date Cleared
    2008-10-27

    (27 days)

    Product Code
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    UC-CARE MEDICAL SYSTEMS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UC-CARE Positioning System is a mechanical positioning device, introduced into the urethra as a sterile urological catheter for visualizing the urethral course, aimed for assistance in diagnostic or therapeutic endorectal ultrasound-guided prostate procedures. The device is retained in place by inflating the balloon tip and by attaching it over an ultrasound-stepper and stabilizer with a Brachy-like template.
    Device Description
    The UCP System is a positioning device used to outline the urethral course during diagnostic or therapeutic transperineal ultrasound-guided prostate procedures. The UCP System combines the function of a positioning and imaging-visibility enhancing device with the configuration of a urological Foley catheter. The configuration and material composition of the patient contact portion of the UCP System part are identical to a commercially available (FDA cleared) urological catheter including a balloon retention mechanism. The device is comprised of two main components: the Urethral Catheter and the Catheter Holder. The device is used together with any commercial endorectal ultrasound stepper and stabilizer as well as brachy-like template grid, available in the market for a transperineal prostate biopsy, brachytherapy, or cryotherapy. The use of the device facilitates simple and safe transperineal needle insertion for diagnostic and therapeutic prostate procedures. The UCP System's Catheter is introduced into the urethra as a sterile urological catheter and is retained in place by inflating the balloon tip and by the Catheter Holder, which is mounted over the ultrasound stepper and stabilizer.
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