FDA product code NZC: Stent, Urethral, Prostatic, Semi-Permanent
NZC is the FDA product code for stent, urethral, prostatic, semi-permanent. It is a Class III device, reviewed by the Gastroenterology and Urology panel. Devices under NZC reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
Approximately 3 cm tube placed in the prostatic urethra for short term use to drain urine. The device includes a retention mechanism that anchors in the bladder neck to hold it in place and a release mechanism that exits the penis. For short term use in men with partial of full prostatic urethral obstruction or the prevention of prostatic urethral obstruction post surgery or other prostatic treatment.
Classification
| Field | Value |
|---|---|
| Device name | Stent, Urethral, Prostatic, Semi-Permanent |
| Device class | Class III |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for NZC devices
openFDA lists no recalls for product code NZC.
Frequently asked questions
What is FDA product code NZC?
NZC is the FDA product code for stent, urethral, prostatic, semi-permanent. It is a Class III device, reviewed by the Gastroenterology and Urology panel.
What device class is NZC?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code NZC
- Run a recall and safety report across every NZC manufacturer
- Watch product code NZC 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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