Device Dossier

Flexible video choledochoscope, single-use

Device Dossier for Flexible video choledochoscope, single-use (Flexible video choledochoscope, single-use, Class IIa, sponsor Sungo). ARTG record,…

Intended purpose

The device is an endoscope with a flexible inserted portion intended for the visual examination and treatment of the biliary tract/ducts and removal of gallstones that can only occur with additional accessories.It is used in conjunction with surgical endoscope or laparoscopic instruments (duodenoscopy, trocar, T-tube, etc.), through the established surgical instrument channel, into the bile duct for observation and diagnosis.

TGA Public Summary