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