FDA product code QWW: Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.
QWW is the FDA product code for non-medicated topical formulation for treatment of erectile dysfunction.. It is a Class II device, regulated under 21 CFR 876.5021 and reviewed by the Gastroenterology and Urology panel. Devices under QWW reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A non-medicated topical formulation for treatment of erectile dysfunction is a device that is applied on the penis and stimulates the nerve endings by inducing a temperature change, leading to tumescence and erection.
Classification
| Field | Value |
|---|---|
| Device name | Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction. |
| Device class | Class II |
| Regulation | 21 CFR 876.5021 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Recalls for QWW devices
openFDA lists no recalls for product code QWW.
Frequently asked questions
What is FDA product code QWW?
QWW is the FDA product code for non-medicated topical formulation for treatment of erectile dysfunction.. It is a Class II device, regulated under 21 CFR 876.5021 and reviewed by the Gastroenterology and Urology panel.
What device class is QWW?
Class II, regulation 21 CFR 876.5021. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QWW
- Run a recall and safety report across every QWW manufacturer
- Watch product code QWW 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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