Device Category Dossier

Balloon, gastric, appetite-suppressing

Device Category Dossier for Balloon, gastric, appetite-suppressing. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Gastric balloon devices are swallowable balloons placed in the stomach via swallowing without endoscopy or sedation, where they reside for approximately 16 weeks, self-empty, and pass through the gastrointestinal tract with no further intervention. These devices are used for temporary weight-loss therapy in patients meeting specified Body Mass Index and health criteria, working by creating a feeling of satiety and reducing the desire for food.