QFQ — Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss Class II

FDA Device Classification

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K240544epitomee medicalEpitomeeSeptember 13, 2024
K230133gelesisPlenityJanuary 19, 2024
DEN180060gelesisPlenityApril 12, 2019