FDA product code OCE: Cultured Epithelial Autograft
OCE is the FDA product code for cultured epithelial autograft. It is a HDE device, reviewed by the General and Plastic Surgery panel. Devices under OCE reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
Definition
Interactive wound and burn dressing containing a live xenogeneic component. Indicated for use in patients who have deep dermal or full thickness burns comprising a total body surface area of greater than or equal to 30%. It may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
Classification
| Field | Value |
|---|---|
| Device name | Cultured Epithelial Autograft |
| Device class | HDE |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for OCE devices
openFDA lists no recalls for product code OCE.
Frequently asked questions
What is FDA product code OCE?
OCE is the FDA product code for cultured epithelial autograft. It is a HDE device, reviewed by the General and Plastic Surgery panel.
What device class is OCE?
HDE. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code OCE
- Run a recall and safety report across every OCE manufacturer
- Watch product code OCE 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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