Device Dossier

Laparoscopic trocar/sleeve, single-use

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

Intended purpose

A sterile, surgical device assembly that includes a single cannula (laparoscopic sleeve) and a sharp rigid intraluminal rod/pin/blade (laparoscopic trocar), intended to puncture the abdominal wall and create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The trocar is intended to fill the lumen of the sleeve during insertion, and is then withdrawn once the sleeve is in situ to provide an access port to the abdominal cavity; a laparoscopic sleeve seal may be included. It is available in a variety of dimensions and/or designs. This is a single-use device.

TGA Public Summary