FDA product code NOA: Device, Paste-On For Incontinence, Non-Sterile
NOA is the FDA product code for device, paste-on for incontinence, non-sterile. It is a Class I device, regulated under 21 CFR 876.5250 and reviewed by the Gastroenterology and Urology panel. Devices under NOA reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Urine collector and accessories; see product code EXI.
Classification
| Field | Value |
|---|---|
| Device name | Device, Paste-On For Incontinence, Non-Sterile |
| Device class | Class I |
| Regulation | 21 CFR 876.5250 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for NOA devices
openFDA lists no recalls for product code NOA.
Frequently asked questions
What is FDA product code NOA?
NOA is the FDA product code for device, paste-on for incontinence, non-sterile. It is a Class I device, regulated under 21 CFR 876.5250 and reviewed by the Gastroenterology and Urology panel.
What device class is NOA?
Class I, regulation 21 CFR 876.5250. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code NOA
- Run a recall and safety report across every NOA manufacturer
- Watch product code NOA 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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