FDA product code POI: Lung Tissue Sealant For Lung Volume Reduction
POI is the FDA product code for lung tissue sealant for lung volume reduction. It is a Not classified device, reviewed by the Anesthesiology panel. Devices under POI reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
The system is intended to reduce lung volume irreversibly by employing a synthetic polymer to seal airways in order to improve lung function and quality of life in patients with advanced emphysema. It functions by physically occluding both small airways and collateral air channels through sealing lung tissue, causing the treated area to collapse via absorption atelectasis. It is a single use device intended to be used by pulmonologists and thoracic surgeons in a bronchoscopy suite or operating room.
Classification
| Field | Value |
|---|---|
| Device name | Lung Tissue Sealant For Lung Volume Reduction |
| Device class | Not classified |
| Review panel | AN — Anesthesiology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
| Implant | Yes |
Recalls for POI devices
openFDA lists no recalls for product code POI.
Frequently asked questions
What is FDA product code POI?
POI is the FDA product code for lung tissue sealant for lung volume reduction. It is a Not classified device, reviewed by the Anesthesiology panel.
What device class is POI?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code POI
- Run a recall and safety report across every POI manufacturer
- Watch product code POI 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.