FDA product code QUN: Tether Accessory For Use In The Gastrointestinal Tract
QUN is the FDA product code for tether accessory for use in the gastrointestinal tract. It is a Class II device, regulated under 21 CFR 876.1305 and reviewed by the Gastroenterology and Urology panel. Devices under QUN reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
A non-powered, detachable, flexible tether accessory used to maneuver a swallowed device, such as a capsule, in the upper gastrointestinal tract.
Classification
| Field | Value |
|---|---|
| Device name | Tether Accessory For Use In The Gastrointestinal Tract |
| Device class | Class II |
| Regulation | 21 CFR 876.1305 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Recalls for QUN devices
openFDA lists no recalls for product code QUN.
Frequently asked questions
What is FDA product code QUN?
QUN is the FDA product code for tether accessory for use in the gastrointestinal tract. It is a Class II device, regulated under 21 CFR 876.1305 and reviewed by the Gastroenterology and Urology panel.
What device class is QUN?
Class II, regulation 21 CFR 876.1305. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QUN
- Run a recall and safety report across every QUN manufacturer
- Watch product code QUN 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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