FDA product code MXQ: Stent, Urethral, External Sphincter, Permanent
MXQ is the FDA product code for stent, urethral, external sphincter, permanent. It is a Class III device, reviewed by the Gastroenterology and Urology panel. Devices under MXQ 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, External Sphincter, Permanent |
| Device class | Class III |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for MXQ devices
openFDA lists no recalls for product code MXQ.
Frequently asked questions
What is FDA product code MXQ?
MXQ is the FDA product code for stent, urethral, external sphincter, permanent. It is a Class III device, reviewed by the Gastroenterology and Urology panel.
What device class is MXQ?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code MXQ
- Run a recall and safety report across every MXQ manufacturer
- Watch product code MXQ 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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