Device Dossier

Electrosurgical system, ultrasonic/mechanical vibration

Device Dossier for Electrosurgical system, ultrasonic/mechanical vibration (Electrosurgical system, ultrasonic/mechanical vibration, Class IIb, sponsor…

Intended purpose

An ultrasonic surgical aspirator console indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue is desirable. This includes neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, orthopedic surgery, gynecological surgery, laparoscopic surgery and cardiac surgery - including debridement of unwanted tissue in cardiac surgeries including valve replacement and valve repair.

TGA Public Summary