Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm (TB2-0520FC)

The Electrosurgical & Ultrasonic Generator (USG-410) is intended to be used with the THUNDERBEAT Transducer, the SONICBEAT Transducer, the THUNDERBEAT or the SONICBEAT for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels. The Reusable Cordless Transducer (TD-410) is intended to be used for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels. The THUNDERBEAT II Shears with Ultrasonic Mode (TB2-0520FC, TB2-0525FC, TB2-0535FC, TB2-0545FC) are intended to be used for open, laparoscopic, and endoscopic surgery to cut, seal, coagulate, grasp, and dissect. The THUNDERBEAT II Shears with Ultrasonic Mode are indicated for general, plastic and reconstructive, gynecologic, urologic, thoracic, and other open, laparoscopic and endoscopic procedures. The THUNDERBEAT II Shears with Ultrasonic Mode have been designed to seal and cut vessels up to and including 7mm in diameter, tissue bundles and lymphatics using with the Seal & Cut mode or the Seal mode. The THUNDERBEAT II shears with Ultrasonic Mode have been designed to seal and cut vessels up to and including 3mm in diameter, tissue bundles and lymphatics using with the Ultrasonic mode.

The Electrosurgical & Ultrasonic Generator (USG-410) is intended to be used with the THUNDERBEAT Transducer, the SONICBEAT Transducer, the THUNDERBEAT or the SONICBEAT for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels. The Reusable Cordless Transducer (TD-410) is intended to be used for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels. The THUNDERBEAT II Shears with Ultrasonic Mode (TB2-0520FC, TB2-0525FC, TB2-0535FC, TB2-0545FC) are intended to be used for open, laparoscopic, and endoscopic surgery to cut, seal, coagulate, grasp, and dissect. The THUNDERBEAT II Shears with Ultrasonic Mode are indicated for general, plastic and reconstructive, gynecologic, urologic, thoracic, and other open, laparoscopic and endoscopic procedures. The THUNDERBEAT II Shears with Ultrasonic Mode have been designed to seal and cut vessels up to and including 7mm in diameter, tissue bundles and lymphatics using with the Seal & Cut mode or the Seal mode. The THUNDERBEAT II shears with Ultrasonic Mode have been designed to seal and cut vessels up to and including 3mm in diameter, tissue bundles and lymphatics using with the Ultrasonic mode.

The following devices are the subject of this premarket (510(k)) submission: THUNDERBEAT II (Model Numbers: TB2-0545FC, TB2-0535FC, TB2-0525FC, TB2-0520FC) – Hand instruments used with an ultrasonic generator and transducer capable of sealing, cutting, grasping and dissecting vessels, tissue bundles, and lymphatic tissue up to 7mm in diameter during open, laparoscopic, and endoscopic surgical procedures. THUNDERBEAT II hand instruments are available in four (4) shaft sizes: 20cm, 25cm, 35cm, and 45cm. Reusable Cordless Transducer (Model Number: TD-410) – A transducer used with the THUNDERBEAT II hand instruments and ultrasonic generator to dissect and/or coagulate soft tissue, or ligate (seal and cut) soft tissue. Ultrasonic Bipolar Generator (Model Number: USG-410) – An ultrasonic bipolar generator used with the compatible hand instruments and transducers to dissect and/or coagulate soft tissue, or ligate (seal and cut) soft tissue. Identical and unchanged from K211838, but modified when accessory MAJ-2467 is used to upgrade USG-410 software version to allow compatibility with THUNDERBEAT II hand instruments. Update Tool for USG-410 (Model Number: MAJ-2467) – A function activation portable memory key accessory used to upgrade the software version of USG-410 to allow compatibility with THUNDERBEAT II hand instruments.