QFQ

Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss

Product code
QFQ
Device name
Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss
Device class
Class 2
21 CFR
21 CFR 876.5982
Medical specialty
Gastroenterology, Urology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
2
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
3 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2024-09-13.

NumberDecision dateApplicantDevice nameSummary
K2405442024-09-13Epitomee Medical , Ltd.EpitomeePDF
K2301332024-01-19Gelesis, Inc.PlenityPDF

2 summaries are archived here for direct download.

Official FDA classification page: QFQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).