Device Dossier

Ultrasonic surgical system generator

Device Dossier for Ultrasonic surgical system generator (Ultrasonic surgical system generator, Class IIb, sponsor Ascend Surgical and Medical). ARTG…

Intended purpose

This system is indicated for soft tissue cutting when bleeding control and minimal thermal injury is desired. It is also indicated for general, gynecologic in open and Laparoscopic surgery. It cannot be used for the blood vessel with close diameter more than 3mm alone. The product is not applicable to bone removal, dental, tubal ligation and neurosurgery.

TGA Public Summary