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510(k) Data Aggregation

    K Number
    K123212
    Device Name
    ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS
    Date Cleared
    2013-03-08

    (144 days)

    Product Code
    Regulation Number
    878.4400
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    Product Code :

    PDG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ethicon Endo Surgery ENSEAL® G2 Cordless Curved Jaw Tissuc Sealers are intended for use during open or laparoscopic, general and gynccological surgery to cut and scal vessels, cut, grasp and dissect tissue during surgery. Indications for use include open and laparoscopic general, gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and scaling), tissue grasping and dissection are performed. The devices can be used on vessels up to (and including) 7mm and bundles as large as will fit in the jaws of the instruments. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.
    Device Description
    The Ethicon Endo-Surgery ENSEAL G2 Cordless Curved Jaw Tissue Sealer is a sterile, single patient use, self-contained, disposable RF electrosurgical instrument. The cordless hand-held device is powered by a Lithium Ion Polymer (LiPo) battery with an RF (radiofrequency) generator integrated into the device handle and does not require connection to an external generator or power source. The integrated generator provides the required RF energy to seal vessels during a surgical procedure. The battery is a DC power source that is charged during manufacturing; the battery cannot be removed from the device, or be recharged by the user. The device is configured with 3mm curved jaw and is intended to cut, grasp and dissect soft tissue, and coagulate and transect vessels up to and including 7mm in diameter.
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