FDA product code GFB: Head, Surgical, Hammer
GFB is the FDA product code for head, surgical, hammer. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the General and Plastic Surgery panel. Devices under GFB reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Head, Surgical, Hammer |
| Device class | Class I |
| Regulation | 21 CFR 878.4820 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Recalls for GFB devices
openFDA lists no recalls for product code GFB.
Frequently asked questions
What is FDA product code GFB?
GFB is the FDA product code for head, surgical, hammer. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the General and Plastic Surgery panel.
What device class is GFB?
Class I, regulation 21 CFR 878.4820. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GFB
- Run a recall and safety report across every GFB manufacturer
- Watch product code GFB 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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