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510(k) Data Aggregation

    K Number
    K201018
    Device Name
    Encision AEM enTouch 2X Scissor
    Manufacturer
    Date Cleared
    2020-07-15

    (89 days)

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

    Encision Inc.

    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
    The AEM enTouch® 2X Scissors Inserts are designed for use with the ES8000 / ES8200 series AEM enTouch® Handles. All scissors will fit through standard 5.5mm trocars.
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    K Number
    K140006
    Device Name
    ENDOSHIELD BURN PROTECTION SYSTEM
    Manufacturer
    Date Cleared
    2014-06-16

    (165 days)

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

    ENCISION INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EndoShield Burn Protection System is an accessory for use with electrosurgical generators and is designed to safely deliver electrosurgical energy and to prevent injury caused by insulation failure and capacitive coupling. EndoShield performs acive electrode monitoring intended to control stray monopolar energy, caused by insulation failure and capacitive coupling in surgical instruments, along the instrument.
    Device Description
    EndoShield is a self-contained battery-powered electronic module (about the size of a cell phone) with integral instrument and HF power cords: • Module plugs directly into return-electrode receptacle of ESU - Integral cords connect module to - AEM laparoscopic instrument - Foot-control power output receptacle of ESU
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