FDA product code QQR: Circumcision Device With Stapler
QQR is the FDA product code for circumcision device with stapler. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Gastroenterology and Urology panel. Devices under QQR reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
To cut and suture / staple the prepuce.
Classification
| Field | Value |
|---|---|
| Device name | Circumcision Device With Stapler |
| Device class | Class II |
| Regulation | 21 CFR 884.4530 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
Recalls for QQR devices
openFDA lists no recalls for product code QQR.
Frequently asked questions
What is FDA product code QQR?
QQR is the FDA product code for circumcision device with stapler. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Gastroenterology and Urology panel.
What device class is QQR?
Class II, regulation 21 CFR 884.4530. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QQR
- Run a recall and safety report across every QQR manufacturer
- Watch product code QQR 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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