FDA product code OUT: Intracranial Aneurysm Flow Diverter
OUT is the FDA product code for intracranial aneurysm flow diverter. It is a Class III device, reviewed by the Neurology panel. Devices under OUT reach the market by PMA; FDA lists no cleared 510(k)s for it. 3 PMA applications cite this product code. FDA has posted 13 recalls for OUT devices, 6 initiated in the last five years.
Definition
Treatment of wide-necked and larger or giant intracranial aneurysms.
Classification
| Field | Value |
|---|---|
| Device name | Intracranial Aneurysm Flow Diverter |
| Device class | Class III |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for OUT devices
13 product recalls in 9 recall events; 6 initiated in the last five years and 8 still open. Most recent: 2026-06-08.
| Year | Recalls |
|---|---|
| 2020 | 2 |
| 2021 | 2 |
| 2023 | 1 |
| 2025 | 3 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code OUT?
OUT is the FDA product code for intracranial aneurysm flow diverter. It is a Class III device, reviewed by the Neurology panel.
What device class is OUT?
Class III. Typical premarket route: PMA.
Have OUT devices been recalled?
Yes: 13 product recalls across 9 recall events; the most recent began 2026-06-08.
Next steps
- Run an FDA pathway report with predicate devices for product code OUT
- Run a recall and safety report across every OUT manufacturer
- Watch product code OUT 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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