510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QFQClass II

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

21 CFR 876.5982 / Gastroenterology, Urology
FDA source (opens on fda.gov)

QFQ is the FDA product code for Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss, a class II device type, regulated under 21 CFR 876.5982. FDA's definition for this code reads: "This device is an ingested material that transiently occupies space in the stomach. The device passes from the body via the natural gastrointestinal tract". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QFQ
Device name
Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss
FDA 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.
Regulation
21 CFR 876.5982
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code QFQ

By decision year
3 clearances under product code QFQ with a decision year between 2019 and 2024, 2024 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QFQ by decision year
YearClearances
20191
20242

Applicants with the most clearances

Product code QFQ
Applicants holding the most 510(k) clearances under product code QFQ
ApplicantClearances
Gelesis SRL2
Epitomee Medical Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code