Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss
The Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss is a swallowed material that transiently occupies space in the stomach to promote satiety and facilitate weight loss, passing naturally from the body through the gastrointestinal tract without surgical removal. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 876.5982 in the Gastroenterology and Urology specialty. The product code is QFQ. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QFQ
- Device Class
- FDA class 2
- Regulation Number
- 876.5982
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.