Device Dossier

SOPRO CO2 Gas Insufflator - Distension unit, gas, laparoscopic

Device Dossier for SOPRO CO2 Gas Insufflator - Distension unit, gas, laparoscopic (Distension unit, gas, laparoscopic, Class IIa, sponsor Erbe). ARTG…

Intended purpose

This device and the associated accessories are intended to create a pneumoperitoneum (distension of the abdominal cavity) by filling with CO2 (at a temperature adapted to that of the human body) at a known pressure and flow rate according to a defined instruction, under the responsibility of the surgeon during a diagnosis or laparoscopic surgery.

TGA Public Summary