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510(k) Data Aggregation

    K Number
    K191612
    Device Name
    Encision AEM Monopolar Laparoscopic Instruments and Accessories
    Date Cleared
    2020-03-20

    (277 days)

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

    Encision Incorporated

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    These AEM Instruments incorporate the use of AEM technology and are intended for use in delivering monopolar electrosurgical energy during laparoscopic procedures only. AEM Instruments are intended for use with the AEM Monitoring System and electrosurgical generators having compatibility with the AEM Monitor. Scissors Inserts are intended for use on soft tissue only.
    Device Description
    Encision AEM® Monopolar Laparoscopic Instruments and Accessories incorporate the use of AEM technology and are intended for use in delivering monopolar electrosurgical energy during laparoscopic procedures only. Encision AEM® Monopolar Laparoscopic Instruments and Accessories are intended for use with the AEM Monitoring System and electrosurgical generators having compatibility with the AEM Monitor. These Encision AEM® Monopolar Laparoscopic Instruments and Accessories include reusable handles and reusable & disposable insert electrodes plus disposable sheath. Encision AEM® Monopolar Laparoscopic Instruments and Accessories, in conjunction with an AEM Monitor properly connected to the electrosurgical generator (ESU), continuously monitor and dynamically manage "stray energy" (insulation failure and capacitive coupling), which are likely out of the surgeon's field of view.
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