FDA product code PUU: Temporary Coil Embolization Assist Device
PUU is the FDA product code for temporary coil embolization assist device. It is a Class II device, regulated under 21 CFR 882.5955 and reviewed by the Neurology panel. Devices under PUU reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A temporary coil embolization assist device is a prescription device intended for temporary use in the neurovasculature to mechanically assist in the embolization of intracranial aneurysms with embolic coils. The device is delivered into the neurovasculature with an endovascular approach. This device is not intended to be permanently implanted and is removed from the body when the procedure is completed.
Classification
| Field | Value |
|---|---|
| Device name | Temporary Coil Embolization Assist Device |
| Device class | Class II |
| Regulation | 21 CFR 882.5955 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
Recalls for PUU devices
openFDA lists no recalls for product code PUU.
Frequently asked questions
What is FDA product code PUU?
PUU is the FDA product code for temporary coil embolization assist device. It is a Class II device, regulated under 21 CFR 882.5955 and reviewed by the Neurology panel.
What device class is PUU?
Class II, regulation 21 CFR 882.5955. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PUU
- Run a recall and safety report across every PUU manufacturer
- Watch product code PUU 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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