FDA product code OWS: Mesh, Surgical, Collagen, Plastics, Facial Implants
OWS is the FDA product code for mesh, surgical, collagen, plastics, facial implants. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the General and Plastic Surgery panel. Devices under OWS reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
For reinforcement of soft tissue where weakness exists in facial plastic surgery.
Classification
| Field | Value |
|---|---|
| Device name | Mesh, Surgical, Collagen, Plastics, Facial Implants |
| Device class | Class II |
| Regulation | 21 CFR 878.3300 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
Recalls for OWS devices
openFDA lists no recalls for product code OWS.
Frequently asked questions
What is FDA product code OWS?
OWS is the FDA product code for mesh, surgical, collagen, plastics, facial implants. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the General and Plastic Surgery panel.
What device class is OWS?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code OWS
- Run a recall and safety report across every OWS manufacturer
- Watch product code OWS 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