Device Dossier

Electrosurgical system generator, general-purpose

Device Dossier for Electrosurgical system generator, general-purpose (Electrosurgical system generator, general-purpose, Class IIb, sponsor B Braun).…

Intended purpose

Electrosurgical unit (ESU) for the cutting of tissue and coagulation of the incision/wound by using high frequency current that is directed through the patient's body between an active and a neutral electrode, or between two active electrodes. The electrosurgical heating effect that causes tissue destruction is provided by tissue resistance to the high frequency, high-density current rather than by heat, as in electrocautery devices.

TGA Public Summary