FDA product code NCV: Lithotripter, Shockwave (For Treating Gallbladder Stones)
NCV is the FDA product code for lithotripter, shockwave (for treating gallbladder stones). It is a Class III device, reviewed by the Gastroenterology and Urology panel. Devices under NCV 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 | Lithotripter, Shockwave (For Treating Gallbladder Stones) |
| Device class | Class III |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for NCV devices
openFDA lists no recalls for product code NCV.
Frequently asked questions
What is FDA product code NCV?
NCV is the FDA product code for lithotripter, shockwave (for treating gallbladder stones). It is a Class III device, reviewed by the Gastroenterology and Urology panel.
What device class is NCV?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code NCV
- Run a recall and safety report across every NCV manufacturer
- Watch product code NCV 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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