FDA product code QON: Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
QON is the FDA product code for implanted electrical device intended for treatment of fecal incontinence. It is a Class III device, regulated under 21 CFR 876.5270 and reviewed by the Gastroenterology and Urology panel. Devices under QON reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code.
Definition
Treatment of chronic fecal incontinence
Classification
| Field | Value |
|---|---|
| Device name | Implanted Electrical Device Intended For Treatment Of Fecal Incontinence |
| Device class | Class III |
| Regulation | 21 CFR 876.5270 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | PMA |
| Implant | Yes |
Recalls for QON devices
openFDA lists no recalls for product code QON.
Frequently asked questions
What is FDA product code QON?
QON is the FDA product code for implanted electrical device intended for treatment of fecal incontinence. It is a Class III device, regulated under 21 CFR 876.5270 and reviewed by the Gastroenterology and Urology panel.
What device class is QON?
Class III, regulation 21 CFR 876.5270. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QON
- Run a recall and safety report across every QON manufacturer
- Watch product code QON 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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