DeviceClearance

Product code QFQ— Gastroenterology, Urology

Plenity

Classification name
Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss
Device class
Class 2
Regulation
21 CFR 876.5982
Advisory panel
Gastroenterology, Urology
Total cleared
3
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QFQ under 21 CFR 876.5982, via openFDA

Market context for product code QFQ

FDA has cleared 3 devices under product code QFQ between 2019 and 2024, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QFQ

Recent clearances under product code QFQ

Data sourced from openFDA. This site is unofficial and independent of the FDA.