Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss
Medical specialty
Gastroenterology, Urology
Device class
2
Regulation number
876.5982
Review panel
GU
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
This device is an ingested material that transiently occupies space in the stomach. The device passes from the body via the natural gastrointestinal tract.