FDA product code ONY: Oral Removable Retainer For Weight Management
ONY is the FDA product code for oral removable retainer for weight management. It is a Class II device, regulated under 21 CFR 876.5981 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under ONY. The average 510(k) review took 28 days (median 28). 1 De Novo request was granted under it.
Definition
A removable oral device used during meals to limit food intake.
Classification
| Field | Value |
|---|---|
| Device name | Oral Removable Retainer For Weight Management |
| Device class | Class II |
| Regulation | 21 CFR 876.5981 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for ONY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 28 |
Top ONY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Scientific Intake | 1 | 2017-05-18 |
Most recent ONY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K171165 | Scientific Intake | SmartByte Device | 2017-05-18 | 28 |
Recalls for ONY devices
openFDA lists no recalls for product code ONY.
Frequently asked questions
What is FDA product code ONY?
ONY is the FDA product code for oral removable retainer for weight management. It is a Class II device, regulated under 21 CFR 876.5981 and reviewed by the Gastroenterology and Urology panel.
What device class is ONY?
Class II, regulation 21 CFR 876.5981. Typical premarket route: 510(k).
How long does a 510(k) take for product code ONY?
Across 1 cleared submissions the average was 28 days from receipt to decision (median 28).
Which companies have the most ONY clearances?
Scientific Intake (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ONY
- Run a recall and safety report across every ONY manufacturer
- Watch product code ONY 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.
All Gastroenterology and Urology product codes · FDA product code lookup