FDA product code SGV: Agent, Absorbable Hemostatic, Collagen With Polymeric Additives
SGV is the FDA product code for agent, absorbable hemostatic, collagen with polymeric additives. It is a Class III device, regulated under 21 CFR 878.4490 and reviewed by the General and Plastic Surgery panel. Devices under SGV reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
An absorbable hemostatic agent or dressing is a device intended to produce hemostasis by accelerating the clotting process of blood.
Classification
| Field | Value |
|---|---|
| Device name | Agent, Absorbable Hemostatic, Collagen With Polymeric Additives |
| Device class | Class III |
| Regulation | 21 CFR 878.4490 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | PMA |
| Implant | Yes |
Recalls for SGV devices
openFDA lists no recalls for product code SGV.
Frequently asked questions
What is FDA product code SGV?
SGV is the FDA product code for agent, absorbable hemostatic, collagen with polymeric additives. It is a Class III device, regulated under 21 CFR 878.4490 and reviewed by the General and Plastic Surgery panel.
What device class is SGV?
Class III, regulation 21 CFR 878.4490. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code SGV
- Run a recall and safety report across every SGV manufacturer
- Watch product code SGV 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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