Device Dossier

Single Use Sterile Laparoscopic Trocar System- IIa - Laparoscopic trocar/sleeve, single-use

Device Dossier for Single Use Sterile Laparoscopic Trocar System- IIa - Laparoscopic trocar/sleeve, single-use (Laparoscopic trocar/sleeve, single-use,…

Intended purpose

A sterile, surgical device assembly that includes a single-lumen sleeve (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 The trocar is intended to fill the lumen of the sleeve during insertion, and is then withdrawn once the sleeve is in situ to provide an access port to the abdominal cavity; a laparoscopic sleeve seal may be included.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. May include an attached accessory, Laparoscopic Filter to remove Surgical Smoke. Filter will include a activated Charcoal filter and ULPA filter. This is system is a single-use device.

TGA Public Summary