FDA product code QGA: Penile Implant Surgical Accessories
QGA is the FDA product code for penile implant surgical accessories. It is a Class I device, regulated under 21 CFR 876.3500 and reviewed by the Gastroenterology and Urology panel. Devices under QGA reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Penile implant surgical accessories are manual devices designed to be used for surgical procedures associated with the implantation of a penile inflatable implant or penile rigidity implant. This generic type of device includes the cylinder sizer, cylinder insertion tool and needle, device placement tool, connector assembly tool, incision closing tool, corporeal dilator, tubing passer, measurement tool or tape, tubing plug, blunt needle, and hemostat shod tubing.
Classification
| Field | Value |
|---|---|
| Device name | Penile Implant Surgical Accessories |
| Device class | Class I |
| Regulation | 21 CFR 876.3500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Recalls for QGA devices
openFDA lists no recalls for product code QGA.
Frequently asked questions
What is FDA product code QGA?
QGA is the FDA product code for penile implant surgical accessories. It is a Class I device, regulated under 21 CFR 876.3500 and reviewed by the Gastroenterology and Urology panel.
What device class is QGA?
Class I, regulation 21 CFR 876.3500. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code QGA
- Run a recall and safety report across every QGA manufacturer
- Watch product code QGA 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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