FDA product code OWO: Drug-Eluting Sinus Stent
OWO is the FDA product code for drug-eluting sinus stent. It is a Class III device, reviewed by the Ear, Nose and Throat panel. Devices under OWO 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 OWO devices, 1 initiated in the last five years.
Definition
Mechanically maintain patency following ethmoid sinus surgery. By also eluting drugs, reduce the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids.
Classification
| Field | Value |
|---|---|
| Device name | Drug-Eluting Sinus Stent |
| Device class | Class III |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for OWO devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-10-21.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code OWO?
OWO is the FDA product code for drug-eluting sinus stent. It is a Class III device, reviewed by the Ear, Nose and Throat panel.
What device class is OWO?
Class III. Typical premarket route: PMA.
Have OWO devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2022-10-21.
Next steps
- Run an FDA pathway report with predicate devices for product code OWO
- Run a recall and safety report across every OWO manufacturer
- Watch product code OWO 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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