FDA product code NUB: Colonic Irrigation System, General Well Being
NUB is the FDA product code for colonic irrigation system, general well being. It is a Class III device, regulated under 21 CFR 876.5220 and reviewed by the Gastroenterology and Urology panel. Devices under NUB reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Call for PMAs on 12/26/96 per 61 FR 50707 on 9/27/96 - Colon cleansing for routine general well being
Classification
| Field | Value |
|---|---|
| Device name | Colonic Irrigation System, General Well Being |
| Device class | Class III |
| Regulation | 21 CFR 876.5220 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | PMA |
Recalls for NUB devices
openFDA lists no recalls for product code NUB.
Frequently asked questions
What is FDA product code NUB?
NUB is the FDA product code for colonic irrigation system, general well being. It is a Class III device, regulated under 21 CFR 876.5220 and reviewed by the Gastroenterology and Urology panel.
What device class is NUB?
Class III, regulation 21 CFR 876.5220. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code NUB
- Run a recall and safety report across every NUB manufacturer
- Watch product code NUB 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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