FDA product code QGE: Biliary Stent, Drain, And Dilator Accessories
QGE is the FDA product code for biliary stent, drain, and dilator accessories. It is a Class I device, regulated under 21 CFR 876.5012 and reviewed by the Gastroenterology and Urology panel. Devices under QGE reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Biliary stent, drain, and dilator accessories are manual devices that aid in the introduction and connection of biliary stents, drains, or dilators. This generic type of device includes the guiding catheter, pushing catheter, pigtail straightener, flap protector, nasal transfer tube, and drainage connecting tube.
Classification
| Field | Value |
|---|---|
| Device name | Biliary Stent, Drain, And Dilator Accessories |
| Device class | Class I |
| Regulation | 21 CFR 876.5012 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Recalls for QGE devices
openFDA lists no recalls for product code QGE.
Frequently asked questions
What is FDA product code QGE?
QGE is the FDA product code for biliary stent, drain, and dilator accessories. It is a Class I device, regulated under 21 CFR 876.5012 and reviewed by the Gastroenterology and Urology panel.
What device class is QGE?
Class I, regulation 21 CFR 876.5012. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code QGE
- Run a recall and safety report across every QGE manufacturer
- Watch product code QGE 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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