65 devices · GMDN 44778
A soft-tissue ultrasonic surgical system is an assembly of devices that uses high-frequency electrical energy to create ultrasonic vibrations at a surgical tip. This vibrating tip mechanically fragments soft tissue upon contact, enabling cutting and/or coagulation during procedures, and may also incorporate irrigation and aspiration functions to manage fluid and debris.
Such systems are regulated as active medical devices that deliver energy to tissue, typically requiring conformity assessment based on their intended use and risk profile. They are supplied as integrated systems comprising a generator, handpieces with interchangeable tips, connecting cables, and optional footswitches or irrigation/suction components, with performance and safety evaluated according to applicable standards for electrosurgical and ultrasonic equipment.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.