Device Category Dossier

Electrosurgical system, ultrasonic/mechanical vibration

Device Category Dossier for Electrosurgical system, ultrasonic/mechanical vibration. Australian ARTG records, sponsors, device class — compiled by…

Ultrasonic surgical equipment converts high-frequency current into ultrasonic oscillation to mechanically fragment soft-tissue cells upon contact with a vibrating tip for cutting and coagulating tissue during surgery, possibly in combination with irrigation and aspiration. These devices are indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important, and may be used as an adjunct to or substitute for electrosurgery, lasers, and traditional scalpels in general, plastic, gynaecologic, urologic, thoracic, and other open and laparoscopic procedures in adult patients.