Device Dossier

Electrosurgical system handpiece, hand-controlled, general-purpose, single-use

Device Dossier for Electrosurgical system handpiece, hand-controlled, general-purpose, single-use (Electrosurgical system handpiece, hand-controlled,…

Intended purpose

A sterile hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to a generator; it is not intended for use during argon-enhanced electrosurgery. This is a single-use device.

TGA Public Summary