FDA product code KGM: Silicone, Liquid, Injectable
KGM is the FDA product code for silicone, liquid, injectable. It is a Class III device, reviewed by the General and Plastic Surgery panel. Devices under KGM reach the market by PMA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Silicone, Liquid, Injectable |
| Device class | Class III |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for KGM devices
openFDA lists no recalls for product code KGM.
Frequently asked questions
What is FDA product code KGM?
KGM is the FDA product code for silicone, liquid, injectable. It is a Class III device, reviewed by the General and Plastic Surgery panel.
What device class is KGM?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code KGM
- Run a recall and safety report across every KGM manufacturer
- Watch product code KGM 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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