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    K Number
    K070711
    Device Name
    INCIRCLE BI-POLAR RF ABLATION SYSTEM
    Manufacturer
    RFA MEDICAL, INC.
    Date Cleared
    2007-04-24

    (41 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    RFA MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RFA Medical InCircle™ Bi-Polar RF Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the thermal coagulation of soft tissues.
    Device Description
    The RFA Medical InCircle™ Bi-Polar RF Ablation System is a sterile, disposable, bi-polar, Radio Frequency (RF), hand-held electrosurgical device that utilizes opposing sets of Electrodes to coagulate/ablate a region of soft tissue using bi-polar RF energy. The device is designed for in percutaneous, laparoscopic, and intraoperative surgical use procedures. The device is designed for use with standard FDA cleared generators, such as the Boston RF Scientific Corporation (RadioTherapeutics) RF3000 (K000241) and the RITA Medical Systems 1500X (K983214).
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