FDA product code GAI: Stripper, Vein, Reusable
GAI is the FDA product code for stripper, vein, reusable. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. Devices under GAI reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Stripper, Vein, Reusable |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Recalls for GAI devices
openFDA lists no recalls for product code GAI.
Frequently asked questions
What is FDA product code GAI?
GAI is the FDA product code for stripper, vein, reusable. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is GAI?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GAI
- Run a recall and safety report across every GAI manufacturer
- Watch product code GAI 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.
All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times