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The SurgRx EnSeal system includes bipolar electrosurgical instruments and a radiofrequency generator. It is intended for use during open or laparoscopic, general and gynecologic surgery to cut and seal vessels, 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 SurgRx EnSeal Vessel Sealing & Hemostasis System has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.

The SurgRx EnSeal devices are intended for use during open or laparoscopic general and gynecologic surgery to cut and seal vessels, cut, grasp and dissect tissue and/or seal vessels during surgery. The SurgRx EnSeal Vessel Sealing & Hemostasis System has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures. The EnSeal electrosurgical instruments are the same as the predicate devices utilizing RF powered bipolar distal ends.

The SurgRx EnSeal system includes bipolar electrosurgical instruments and a radiofrequency generator. It is intended for use during open or laparoscopic, general and gynecologic surgery to cut and seal vessels, 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 researcines, 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 SurgRx EnSeal Vessel Sealing & Hemostasis System has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.

EnSeal™ Vessel Sealing & Hemostasis System. The functionality of the System is the same as the Predicate Device. The EnSeal electrosurgical instruments are the same as the predicate devices utilizing RF powered bipolar distal ends.

The SurgRx EnSeal system includes bipolar electrosurgical instruments and an accessory adapter for use with standard electrosurgical generators. It is intended for use during open or laparoscopic, general and general and general to cut and seal vesses, cut, grasp and dissect tissue during surgery. Indications for use include open and laparoscopic general and gynecological surgical procedures (including unologic, 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 SurgHx EnSeal Vessel Sealing & Hemostasis System has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.

The EnSeal Laparoscopic devices are tubular instruments with grasping jaws at the distal end, which are actuated by a handle at the proximal end of the device. The distal end contains bipolar electrodes for sealing vessels, and a mechanical cutting blade for transecting vessels. The EnSeal Open devices are reusable forceps-type devices with one snap-in single use, disposable bipolar electrode, and one permanent, reusable electrode in the jaws of the device. Connectors attached to an electrical cable connect the device to the ECA (EnSeal Controller Adapter) accessory which connects the device to a standard O.R. electrosurgical generator.