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510(k) Data Aggregation

    K Number
    K082954
    Device Name
    ENCAGE BIPOLAR RF PROBE
    Manufacturer
    TROD MEDICAL SA
    Date Cleared
    2008-10-17

    (14 days)

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

    TROD MEDICAL SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ENCAGE™ bipolar RF probe is intended to be used in conjunction with radiofrequency (RF) generators for percutaneous, laparoscopic, or intraoperative thermal coagulation of soft tissues.
    Device Description
    The ENCAGE™ bipolar RF probe is a sterile, disposable, bi-polar, Radio Frequency (RF), hand-held electrosurgical device that coagulate/ablate a region of soft tissue using bipolar RF energy. The device is designated for use in percutaneous, laparoscopic and intraoperative surgical procedures. The ENCAGE™ bipolar RF probe is used in conjunction with the Stockert NEURO N50 RF Generator and Interconnect Cables to create radiofrequency lesions in soft tissue.
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