FDA product code OZJ: Inhibitor, Postoperative Fibrosis (Adhesion Barrier)
OZJ is the FDA product code for inhibitor, postoperative fibrosis (adhesion barrier). It is a Not classified device, reviewed by the Neurology panel. Devices under OZJ reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
The device is designed to coat surfaces exposed in tendon and peripheral nerve surgery, in order to form a temporary mechanical barrier that separates tissues for the purpose of reducing fibrosis and reducing the formation of adhesions.
Classification
| Field | Value |
|---|---|
| Device name | Inhibitor, Postoperative Fibrosis (Adhesion Barrier) |
| Device class | Not classified |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for OZJ devices
openFDA lists no recalls for product code OZJ.
Frequently asked questions
What is FDA product code OZJ?
OZJ is the FDA product code for inhibitor, postoperative fibrosis (adhesion barrier). It is a Not classified device, reviewed by the Neurology panel.
What device class is OZJ?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code OZJ
- Run a recall and safety report across every OZJ manufacturer
- Watch product code OZJ 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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