FDA product code QGC: Suprapubic Catheter Accessories
QGC is the FDA product code for suprapubic catheter accessories. It is a Class I device, regulated under 21 CFR 876.5100 and reviewed by the Gastroenterology and Urology panel. Devices under QGC reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Suprapubic catheter accessories are manual devices that are used to facilitate the placement of a suprapubic catheter. This generic type of device includes the introducer, access dilator, and peel-away sheath.
Classification
| Field | Value |
|---|---|
| Device name | Suprapubic Catheter Accessories |
| Device class | Class I |
| Regulation | 21 CFR 876.5100 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Recalls for QGC devices
openFDA lists no recalls for product code QGC.
Frequently asked questions
What is FDA product code QGC?
QGC is the FDA product code for suprapubic catheter accessories. It is a Class I device, regulated under 21 CFR 876.5100 and reviewed by the Gastroenterology and Urology panel.
What device class is QGC?
Class I, regulation 21 CFR 876.5100. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code QGC
- Run a recall and safety report across every QGC manufacturer
- Watch product code QGC 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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