Device Dossier

Catheter, gastrointestinal balloon

Device Dossier for Catheter, gastrointestinal balloon (Catheter, gastrointestinal balloon, Class IIa, sponsor Fujifilm). ARTG record, intended purpose,…

Intended purpose

This is a balloon intended to be used in combination with Endoscope, assists insertion of Endoscope into the small intestine at a medical facility under the management of a physician. This product is not intended for use for any child or baby.

TGA Public Summary