ONYClass II
Oral Removable Retainer For Weight Management
21 CFR 876.5981 / Gastroenterology, Urology
ONY is the FDA product code for Oral Removable Retainer For Weight Management, a class II device type, regulated under 21 CFR 876.5981. FDA's definition for this code reads: "A removable oral device used during meals to limit food intake". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- ONY
- Device name
- Oral Removable Retainer For Weight Management
- FDA definition
- A removable oral device used during meals to limit food intake.
- Regulation
- 21 CFR 876.5981
- 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
- 2
- Ingested recalls
- 0
Clearances, product code ONY
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2017 | 1 |
Applicants with the most clearances
Product code ONY| Applicant | Clearances |
|---|---|
| Scientific Intake | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code ONY.
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