FDA product code NWP: Suprapubic Cystostomy Catheter Kit
NWP is the FDA product code for suprapubic cystostomy catheter kit. It is a Class II device, regulated under 21 CFR 876.5090 and reviewed by the Gastroenterology and Urology panel. Devices under NWP reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Classification
| Field | Value |
|---|---|
| Device name | Suprapubic Cystostomy Catheter Kit |
| Device class | Class II |
| Regulation | 21 CFR 876.5090 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Recalls for NWP devices
openFDA lists no recalls for product code NWP.
Frequently asked questions
What is FDA product code NWP?
NWP is the FDA product code for suprapubic cystostomy catheter kit. It is a Class II device, regulated under 21 CFR 876.5090 and reviewed by the Gastroenterology and Urology panel.
What device class is NWP?
Class II, regulation 21 CFR 876.5090. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code NWP
- Run a recall and safety report across every NWP manufacturer
- Watch product code NWP 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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