FDA product code PFE: Gastrointestinal Liner System
PFE is the FDA product code for gastrointestinal liner system. It is a Not classified device, reviewed by the Gastroenterology and Urology panel. Devices under PFE reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
for the treatment of type 2 diabetes. The gastrointestinal liner is indicated for a maximum of 12 months.
Classification
| Field | Value |
|---|---|
| Device name | Gastrointestinal Liner System |
| Device class | Not classified |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
| Implant | Yes |
Recalls for PFE devices
openFDA lists no recalls for product code PFE.
Frequently asked questions
What is FDA product code PFE?
PFE is the FDA product code for gastrointestinal liner system. It is a Not classified device, reviewed by the Gastroenterology and Urology panel.
What device class is PFE?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code PFE
- Run a recall and safety report across every PFE manufacturer
- Watch product code PFE 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.
All Gastroenterology and Urology product codes · FDA product code lookup