FDA product code PZU: Bone Marrow Processing Device For Clinical Use
PZU is the FDA product code for bone marrow processing device for clinical use. It is a Not classified device, reviewed by the Hematology panel. Devices under PZU reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
Preparation of concentrated bone marrow aspirate (cBMA) from a sample of bone marrow for clinical use
Classification
| Field | Value |
|---|---|
| Device name | Bone Marrow Processing Device For Clinical Use |
| Device class | Not classified |
| Review panel | HE — Hematology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for PZU devices
openFDA lists no recalls for product code PZU.
Frequently asked questions
What is FDA product code PZU?
PZU is the FDA product code for bone marrow processing device for clinical use. It is a Not classified device, reviewed by the Hematology panel.
What device class is PZU?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code PZU
- Run a recall and safety report across every PZU manufacturer
- Watch product code PZU 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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