FDA product code SGU: Neurovascular Liquid Embolic Agent
SGU is the FDA product code for neurovascular liquid embolic agent. It is a Class III device, reviewed by the Neurology panel. Devices under SGU reach the market by PMA; FDA lists no cleared 510(k)s for it. 3 PMA applications cite this product code.
Definition
Arterial occlusion of the middle meningeal artery for treatment of symptomatic subdural hematoma.
Classification
| Field | Value |
|---|---|
| Device name | Neurovascular Liquid Embolic Agent |
| Device class | Class III |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for SGU devices
openFDA lists no recalls for product code SGU.
Frequently asked questions
What is FDA product code SGU?
SGU is the FDA product code for neurovascular liquid embolic agent. It is a Class III device, reviewed by the Neurology panel.
What device class is SGU?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code SGU
- Run a recall and safety report across every SGU manufacturer
- Watch product code SGU 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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