FDA product code OUU: Polymeric Neurovascular Embolization
OUU is the FDA product code for polymeric neurovascular embolization. It is a HDE device, reviewed by the Neurology panel. Devices under OUU reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
Definition
Treatment of intracranial aneurysms
Classification
| Field | Value |
|---|---|
| Device name | Polymeric Neurovascular Embolization |
| Device class | HDE |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
| Implant | Yes |
Recalls for OUU devices
openFDA lists no recalls for product code OUU.
Frequently asked questions
What is FDA product code OUU?
OUU is the FDA product code for polymeric neurovascular embolization. It is a HDE device, reviewed by the Neurology panel.
What device class is OUU?
HDE. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code OUU
- Run a recall and safety report across every OUU manufacturer
- Watch product code OUU 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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