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The EnSeal® Vessel Sealing and Hemostasis System is a bipolar electrosurgical instrument for use with an electrosurgical generator. It is intended for use during open and 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 and 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® Vessel Sealing and Hemostasis System is a bipolar electrosurgical instrument for use with an electrosurgical generator.

I apologize, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the EnSeal® Vessel Sealing and Hemostasis System. The document is a 510(k) clearance letter from the FDA, confirming the device's substantial equivalence to predicate devices and outlining its intended indications for use. It does not include details about specific performance metrics or clinical study data.

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