FDA product code MER: Stent, Urethral, Prostatic, Permanent Or Semi-Permanent
MER is the FDA product code for stent, urethral, prostatic, permanent or semi-permanent. It is a Class III device, reviewed by the Gastroenterology and Urology panel. Devices under MER reach the market by PMA; FDA lists no cleared 510(k)s for it. 3 PMA applications cite this product code.
Classification
| Field | Value |
|---|---|
| Device name | Stent, Urethral, Prostatic, Permanent Or Semi-Permanent |
| Device class | Class III |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MER devices
openFDA lists no recalls for product code MER.
Frequently asked questions
What is FDA product code MER?
MER is the FDA product code for stent, urethral, prostatic, permanent or semi-permanent. It is a Class III device, reviewed by the Gastroenterology and Urology panel.
What device class is MER?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code MER
- Run a recall and safety report across every MER manufacturer
- Watch product code MER 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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