Device Dossier

Endoscopic electrosurgical electrode, monopolar, single-use

Device Dossier for Endoscopic electrosurgical electrode, monopolar, single-use (Endoscopic electrosurgical electrode, monopolar, single-use, Class IIb,…

Intended purpose

The Monopolar L- Hook, Spatula, Needle and Button electrodes are Sterile and for Single-Use only. The Monopolar electrodes need to be connected to a separate controller (typically handpiece or foot switch) and form the distal component of an electrosurgical system. The Monopolar electrodes deliver electrosurgical current in a monopolar configuration to tissues for cutting/coagulation and ablation. These electrodes are used laparoscopically and have a separate lumen for Suction and Irrigation. The electrodes also feature a retractable electrode tip during suction and irrigation for enhanced patient safety.

TGA Public Summary