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