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