Device Dossier

Electrode, electrosurgical, active, ultrasonic/mechanical vibration, single-use

Device Dossier for Electrode, electrosurgical, active, ultrasonic/mechanical vibration, single-use (Soft-tissue ultrasonic surgical system handpiece tip,…

Intended purpose

Probes, Blades and Tips are intended to be used with the Ultrasonic Surgical Systems for use in the fragmentation, disection and/or aspiration of both soft and hard (e.g.: bone) tissue in the following surgical specialties: neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, plastic and reconstructive surgery, general surgery, orthopedic surgery, gynecology, and thoracic surgery podiatry. The device is also intended for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement.

TGA Public Summary