FDA product code MRE: Solution, Sodium Hyaluronate
MRE is the FDA product code for solution, sodium hyaluronate. It is a Class III device, reviewed by the Gastroenterology and Urology panel. Devices under MRE reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Solution, Sodium Hyaluronate |
| Device class | Class III |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for MRE devices
openFDA lists no recalls for product code MRE.
Frequently asked questions
What is FDA product code MRE?
MRE is the FDA product code for solution, sodium hyaluronate. It is a Class III device, reviewed by the Gastroenterology and Urology panel.
What device class is MRE?
Class III. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code MRE
- Run a recall and safety report across every MRE manufacturer
- Watch product code MRE 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