FDA product code OPR: Intrasaccular Flow Disruption Device
OPR is the FDA product code for intrasaccular flow disruption device. It is a Class III device, reviewed by the Neurology panel. Devices under OPR reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 1 recall for OPR devices, 1 initiated in the last five years.
Definition
An intrasaccular flow disruption device is intended for use to treat wide-neck intracranial aneurysms in the neurovasculature through an endovascular approach.
Classification
| Field | Value |
|---|---|
| Device name | Intrasaccular Flow Disruption Device |
| Device class | Class III |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for OPR devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-09-21.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code OPR?
OPR is the FDA product code for intrasaccular flow disruption device. It is a Class III device, reviewed by the Neurology panel.
What device class is OPR?
Class III. Typical premarket route: PMA.
Have OPR devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2022-09-21.
Next steps
- Run an FDA pathway report with predicate devices for product code OPR
- Run a recall and safety report across every OPR manufacturer
- Watch product code OPR 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.