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