Device Dossier

Endotherapy device, non-active, single use

Device Dossier for Endotherapy device, non-active, single use (Endotherapy device, non-active, single use, Class IIa, sponsor Endotherapeutics). ARTG…

Intended purpose

A device used in combination with a dedicated endoscope during endotherapy. It is used for mechanical work, e.g. grasping tissue or foreign bodies, feeding medicinal liquid, or dilating a tract/lumen. It functions without electricity, including e.g. high frequency, electromagnetic, ultrasonic or laser energy. It is disposable.

TGA Public Summary