FDA product code QFQ: Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss
QFQ is the FDA product code for ingested, transient, space occupying device for weight management and/or weight loss. It is a Class II device, regulated under 21 CFR 876.5982 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 2 510(k) submissions under QFQ, 2 in the last five years, from 2 different applicants. The average 510(k) review took 283 days (median 283); 283 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss |
| Device class | Class II |
| Regulation | 21 CFR 876.5982 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for QFQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 2 | 283 |
Compare with all 510(k) review times · Search every QFQ clearance
Top QFQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Epitomee Medical , Ltd. | 1 | 2024-09-13 |
| Gelesis, Inc. | 1 | 2024-01-19 |
Most recent QFQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240544 | Epitomee Medical , Ltd. | Epitomee | 2024-09-13 | 199 |
| K230133 | Gelesis, Inc. | Plenity | 2024-01-19 | 367 |
Recalls for QFQ devices
openFDA lists no recalls for product code QFQ.
Frequently asked questions
What is FDA product code QFQ?
QFQ is the FDA product code for ingested, transient, space occupying device for weight management and/or weight loss. It is a Class II device, regulated under 21 CFR 876.5982 and reviewed by the Gastroenterology and Urology panel.
What device class is QFQ?
Class II, regulation 21 CFR 876.5982. Typical premarket route: 510(k).
How long does a 510(k) take for product code QFQ?
Across 2 cleared submissions the average was 283 days from receipt to decision (median 283).
Which companies have the most QFQ clearances?
Epitomee Medical , Ltd. (1); Gelesis, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QFQ
- Run a recall and safety report across every QFQ manufacturer
- Watch product code QFQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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