Device Dossier

Electrosurgical diathermy/ultrasonic surgical generator

Device Dossier for Electrosurgical diathermy/ultrasonic surgical generator (Electrosurgical/ultrasonic surgical system generator, Class IIb, sponsor…

Intended purpose

Generator used with ultrasonic dissection device which is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The device can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, urologic, and other open and endoscopic procedures. The ultrasonic dissection device can be used to coagulate isolated vessels and is also indicated for use in otorhinolaryngologic (ENT) procedures.

TGA Public Summary