FDA product code QAG: Endoscopic Electrosurgical Clip Cutting System
QAG is the FDA product code for endoscopic electrosurgical clip cutting system. It is a Class II device, regulated under 21 CFR 876.4310 and reviewed by the Gastroenterology and Urology panel. Devices under QAG reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
To fragment metallic clips and remove them from the digestive tract.
Classification
| Field | Value |
|---|---|
| Device name | Endoscopic Electrosurgical Clip Cutting System |
| Device class | Class II |
| Regulation | 21 CFR 876.4310 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
Recalls for QAG devices
openFDA lists no recalls for product code QAG.
Frequently asked questions
What is FDA product code QAG?
QAG is the FDA product code for endoscopic electrosurgical clip cutting system. It is a Class II device, regulated under 21 CFR 876.4310 and reviewed by the Gastroenterology and Urology panel.
What device class is QAG?
Class II, regulation 21 CFR 876.4310. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QAG
- Run a recall and safety report across every QAG manufacturer
- Watch product code QAG 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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