FDA product code MES: Stent, Urethral, Bulbous, Permanent Or Semi-Permanent
MES is the FDA product code for stent, urethral, bulbous, permanent or semi-permanent. It is a Class III device, reviewed by the Gastroenterology and Urology panel. Devices under MES reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | Stent, Urethral, Bulbous, Permanent Or Semi-Permanent |
| Device class | Class III |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MES devices
openFDA lists no recalls for product code MES.
Frequently asked questions
What is FDA product code MES?
MES is the FDA product code for stent, urethral, bulbous, permanent or semi-permanent. It is a Class III device, reviewed by the Gastroenterology and Urology panel.
What device class is MES?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code MES
- Run a recall and safety report across every MES manufacturer
- Watch product code MES 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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