FDA product code QQS: Stapler, Skin
QQS is the FDA product code for stapler, skin. It is a Class I device, regulated under 21 CFR 878.4740 and reviewed by the General and Plastic Surgery panel. Devices under QQS reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
A surgical stapler for external use is a specialized prescription device used to deliver compatible staples to skin during surgery.
Classification
| Field | Value |
|---|---|
| Device name | Stapler, Skin |
| Device class | Class I |
| Regulation | 21 CFR 878.4740 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Recalls for QQS devices
openFDA lists no recalls for product code QQS.
Frequently asked questions
What is FDA product code QQS?
QQS is the FDA product code for stapler, skin. It is a Class I device, regulated under 21 CFR 878.4740 and reviewed by the General and Plastic Surgery panel.
What device class is QQS?
Class I, regulation 21 CFR 878.4740. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code QQS
- Run a recall and safety report across every QQS manufacturer
- Watch product code QQS 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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