FDA product code GBY: Catheter, Eustachian, General & Plastic Surgery
GBY is the FDA product code for catheter, eustachian, general & plastic surgery. It is a Class I device, regulated under 21 CFR 878.4200 and reviewed by the General and Plastic Surgery panel. Devices under GBY reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Eustachian, General & Plastic Surgery |
| Device class | Class I |
| Regulation | 21 CFR 878.4200 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Recalls for GBY devices
openFDA lists no recalls for product code GBY.
Frequently asked questions
What is FDA product code GBY?
GBY is the FDA product code for catheter, eustachian, general & plastic surgery. It is a Class I device, regulated under 21 CFR 878.4200 and reviewed by the General and Plastic Surgery panel.
What device class is GBY?
Class I, regulation 21 CFR 878.4200. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GBY
- Run a recall and safety report across every GBY manufacturer
- Watch product code GBY 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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