QFQ — Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss Class II
FDA product code QFQ covers "Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss", a Class II medical device regulated under 21 CFR 876.5982. Submissions are reviewed by the Gastroenterology, Urology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QFQ
- Device Class
- Class II
- Regulation Number
- 876.5982
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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.