FDA product code QXH: Gallbladder Drainage Stent And Delivery System
QXH is the FDA product code for gallbladder drainage stent and delivery system. It is a Class II device, regulated under 21 CFR 876.5016 and reviewed by the Gastroenterology and Urology panel. Devices under QXH 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 gallbladder drainage stent is a prescription device intended to facilitate transgastric or transduodenal endoscopic drainage of the gallbladder. This device may also include a delivery system.
Classification
| Field | Value |
|---|---|
| Device name | Gallbladder Drainage Stent And Delivery System |
| Device class | Class II |
| Regulation | 21 CFR 876.5016 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Implant | Yes |
Recalls for QXH devices
openFDA lists no recalls for product code QXH.
Frequently asked questions
What is FDA product code QXH?
QXH is the FDA product code for gallbladder drainage stent and delivery system. It is a Class II device, regulated under 21 CFR 876.5016 and reviewed by the Gastroenterology and Urology panel.
What device class is QXH?
Class II, regulation 21 CFR 876.5016. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QXH
- Run a recall and safety report across every QXH manufacturer
- Watch product code QXH 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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