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The ENSEAL® G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. The devices are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic, general and gynecological surgery to cut and seal vessels, and to cut, grasp and dissect tissue during surgery. Indications for use include open and laparoscopic, general and 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 sealing), tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the instruments. The ENSEAL® G2 Tissue Sealers have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use these devices for these procedures.

The Ethicon Endo-Surgery ENSEAL G2 Tissue Sealers are for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. The devices allow the surgeon to grasp, coagulate, and transect soft tissue with a single instrument. The devices are hand-actuated with a shaft and tissue effector that can be rotated. The energy delivery can be activated with hand activation or with a foot switch.

The Generator GI I provides radiofrequency power to drive EnSeal® electrosurgical instruments that are used during open or laparoscopic general and gynecological surgery to cut and seal vessels and to cut, grasp, and dissect tissue. In addition the generator provides power to drive Harmonic ultrasonic surgical instruments that are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. EnSeal® and Harmonic® instruments when used with the Generator G11 have not been shown to be effective for sterilization procedures or tubal coagulation. Do not use these instruments for these procedures.

The Ethicon Endo-Surgery Generator G11 supplies energy to EnSeal® electrosurgical instruments and Harmonic ultrasonic surgical instruments. The generator utilizes a touchscreen display interface and has a receptacle port that accepts either EnSeal® or Harmonic® devices. Connectors (one for Harmonic and one for EnSeal® instruments) are used to enable the generator to power currently cleared surgical instruments.

The 5 mm Endoscopic Multiple Clip Applier is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated.

The Ethicon Endo-Surgery Ligamax 5 is a 5 mm endoscopic multiple clip applier. This sterile, single patient use, instrument is designed to provide a means of ligation on tubular structures or vessels through an appropriately-sized trocar. The instrument contains 15 medium-large titanium clips for occluding tissue, structures, and vessels.

The ETHICON ENDO-SURGERY Single Site Laparoscopic Seal Cap Assembly with accessories and Fixed-Length Access Retractors have application in abdominal, colorectal, urologic, and gynecologic minimally invasive procedures to establish a path of entry for multiple minimally invasive instruments and for extraction of large specimens.

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The Echelon Endoscopic Linear Cutters and Cartridges are intended for transaction, resection, and/or anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.

The Echelon devices are sterile, single-use instruments that deliver staples while simultaneously dividing tissue between rows. These devices may be used in either open or Endoscopic procedures, depending upon the design. The device is intended for use in transection and resection of tissue during multiple open or minimally invasive surgical procedures. They are intended for use in the creation of anastomoses in these procedures. The instruments are reloadable and, as such, they may be reloaded with various cartridges depending on the thickness of tissue that is to be transected or resected. The Echelon Zebra cartridge is a storage case that contains implantable staples. The cartridge is loaded into an Echelon instrument. When the instrument is deployed, it cuts a surgical wound while simultaneously delivering the staples into the tissue. As in the predicate Echclon cartridge, the Zebra cartridges are available in 60 mm lengths. Zebra cartridges will also be available in a 45 mm length for use with the 45mm instruments. There are 70 staples in the 45mm length cartridge and 88 staplers in the 60 mm length cartridge. Cartridges deliver the staples in a predetermined staple row configuration or pattern in relation to the cut line. The staple row configurations of both the predicate and the new device have 6 staples, 3 staples on either side of the cut line. The staple row configuration (or pattern) of the prodicate device is straight. That is to say, all 6 staples are of the same height and formation. The Zebra cartridge staple row configuration is step-wise. This means that of the 6 staples, the two outer most staples are of a taller height and formation than the 4 inner staples.