FDA product code PFU: Tissue Processing Kit
PFU is the FDA product code for tissue processing kit. It is a Not classified device, reviewed by the Pathology panel. Devices under PFU reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
For the preparation of human tissue specimens for frozen sectioning and histological examination.
Classification
| Field | Value |
|---|---|
| Device name | Tissue Processing Kit |
| Device class | Not classified |
| Review panel | PA — Pathology |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
Recalls for PFU devices
openFDA lists no recalls for product code PFU.
Frequently asked questions
What is FDA product code PFU?
PFU is the FDA product code for tissue processing kit. It is a Not classified device, reviewed by the Pathology panel.
What device class is PFU?
Not classified. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PFU
- Run a recall and safety report across every PFU manufacturer
- Watch product code PFU 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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