FDA product code FAC: Valve, Ureterovesicle
FAC is the FDA product code for valve, ureterovesicle. It is a Class III device, reviewed by the Gastroenterology and Urology panel. Devices under FAC reach the market by PMA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Valve, Ureterovesicle |
| Device class | Class III |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for FAC devices
openFDA lists no recalls for product code FAC.
Frequently asked questions
What is FDA product code FAC?
FAC is the FDA product code for valve, ureterovesicle. It is a Class III device, reviewed by the Gastroenterology and Urology panel.
What device class is FAC?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code FAC
- Run a recall and safety report across every FAC manufacturer
- Watch product code FAC 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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