FDA product code OOY: Bronchial Thermoplasty System
OOY is the FDA product code for bronchial thermoplasty system. It is a Class III device, reviewed by the Anesthesiology panel. Devices under OOY 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 OOY devices.
Definition
Bronchial thermoplasty systems are intended for the treatment of severe persistent asthma in patients whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists to reduce the effects of their asthma by using thermal radiofrequency energy to ablate smooth muscle tissue in the patient's airways.
Classification
| Field | Value |
|---|---|
| Device name | Bronchial Thermoplasty System |
| Device class | Class III |
| Review panel | AN — Anesthesiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for OOY devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-05-28.
Frequently asked questions
What is FDA product code OOY?
OOY is the FDA product code for bronchial thermoplasty system. It is a Class III device, reviewed by the Anesthesiology panel.
What device class is OOY?
Class III. Typical premarket route: PMA.
Have OOY devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-05-28.
Next steps
- Run an FDA pathway report with predicate devices for product code OOY
- Run a recall and safety report across every OOY manufacturer
- Watch product code OOY 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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