Device Dossier

Balloon, gastric, appetite-suppressing

Device Dossier for Balloon, gastric, appetite-suppressing (Balloon, gastric, appetite-suppressing, Class IIb, sponsor Emergo). ARTG record, intended…

Intended purpose

This device is the main component of the a Gastric Balloon System. The device is a swallowable, gastric balloon for weight loss that is naturally excreted. The Balloon is placed in the stomach via swallowing without endoscopy or sedation, resides there for approximately 16 weeks, self-empties, and passes through the gastrointestinal tract with no further intervention.

TGA Public Summary