FDA product code QGB: Ureteral Stent Accessories
QGB is the FDA product code for ureteral stent accessories. It is a Class I device, regulated under 21 CFR 876.4630 and reviewed by the Gastroenterology and Urology panel. Devices under QGB reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Ureteral stent accessories aid in the insertion of the ureteral stent that is placed into the ureter to provide ureteral rigidity and allow the passage of urine. This generic type of device includes the stent positioner, wire guide, and pigtail straightener.
Classification
| Field | Value |
|---|---|
| Device name | Ureteral Stent Accessories |
| Device class | Class I |
| Regulation | 21 CFR 876.4630 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Recalls for QGB devices
openFDA lists no recalls for product code QGB.
Frequently asked questions
What is FDA product code QGB?
QGB is the FDA product code for ureteral stent accessories. It is a Class I device, regulated under 21 CFR 876.4630 and reviewed by the Gastroenterology and Urology panel.
What device class is QGB?
Class I, regulation 21 CFR 876.4630. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code QGB
- Run a recall and safety report across every QGB manufacturer
- Watch product code QGB 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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