FDA Product Code QFQ: Ingested, Transient, Space Occupying Device For Weight Management And/or Weight Loss
This Device Is An Ingested Material That Transiently Occupies Space In The Stomach. The Device Passes From The Body Via The Natural Gastrointestinal Tract.
Leading manufacturers include Gelesis, Inc. and Epitomee Medical , Ltd..
FDA 510(k) Cleared Ingested, Transient, Space Occupying Device For Weight Management And/or Weight Loss Devices (Product Code QFQ)
About Product Code QFQ - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code QFQ since 2019, with 2 receiving FDA clearance (average review time: 238 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under QFQ have taken an average of 199 days to reach a decision - down from 258 days historically, suggesting improved FDA processing for this classification.
QFQ devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →