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., Epitomee Medical , Ltd. and Gelesis SRL.
4
Total
3
Cleared
210d
Avg days
2019
Since
Declining activity -
1 submissions in the last 2 years
vs 2 in the prior period
Review times improving: avg
126d
recently vs 238d historically
FDA 510(k) Cleared Ingested, Transient, Space Occupying Device For Weight Management And/or Weight Loss Devices (Product Code QFQ)
4 devices
Cleared
Oct 02, 2026
Plenity-V (MC0979 / GS110)
Gelesis SRL
Gastroenterology & Urology
126d
Cleared
Sep 13, 2024
Epitomee
Epitomee Medical , Ltd.
Gastroenterology & Urology
199d
Cleared
Jan 19, 2024
Plenity
Gelesis, Inc.
Gastroenterology & Urology
367d
Not Cleared
Apr 12, 2019
Plenity
Gelesis, Inc.
Gastroenterology & Urology
148d
About Product Code QFQ - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code QFQ since 2019, with 3 receiving FDA clearance (average review time: 210 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA 510(k) Review Time - QFQ Product Code
Recent submissions under QFQ have taken an average of 126 days to reach a decision - down from 238 days historically, suggesting improved FDA processing for this classification.
QFQ devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →