Device Dossier

Laparoscopic trocar/sleeve, single-use

Device Dossier for Laparoscopic trocar/sleeve, single-use (Laparoscopic trocar/sleeve, single-use, Class IIa, sponsor ConMed Linvatec). ARTG record,…

Intended purpose

A sterile, single-use, surgical device comprising a laparoscopic sleeve and a rigid intraluminal laparoscopic trocar, intended to create an access port for a laparoscope / laparoscopic / thoracoscopic instrument during abdominal, thoracic or paediatric procedures (greater than 20kg); endoscopic observation, diagnosis and treatment of the rectum or colon; and to evacuate surgical smoke. The trocar is intended to fill the lumen of the sleeve during insertion and is withdrawn once the sleeve is in situ.

TGA Public Summary