FDA product code OYF: Aspiration Therapy System
OYF is the FDA product code for aspiration therapy system. It is a Class III device, reviewed by the Gastroenterology and Urology panel. Devices under OYF reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
Percutaneous gastric implant to remove stomach contents after eating for weight loss in the treatment of obesity in adults
Classification
| Field | Value |
|---|---|
| Device name | Aspiration Therapy System |
| Device class | Class III |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for OYF devices
openFDA lists no recalls for product code OYF.
Frequently asked questions
What is FDA product code OYF?
OYF is the FDA product code for aspiration therapy system. It is a Class III device, reviewed by the Gastroenterology and Urology panel.
What device class is OYF?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code OYF
- Run a recall and safety report across every OYF manufacturer
- Watch product code OYF 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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