FDA product code ODS: Wound Covering (Composite Cultured Skin)
ODS is the FDA product code for wound covering (composite cultured skin). It is a HDE device, reviewed by the General and Plastic Surgery panel. Devices under ODS reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
Definition
Wound covering. Indicated for use in patients with mitten hand deformities due to recessive dystrophic epidermolysis bullosa (rdeb) as an adjunct to standard autograft procedures (i.E., skin grafts and flaps) for covering wounds and donor sites created after the surgical release of hand contractures (i.E., ?mitten? hand deformities).
Classification
| Field | Value |
|---|---|
| Device name | Wound Covering (Composite Cultured Skin) |
| Device class | HDE |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
| Implant | Yes |
Recalls for ODS devices
openFDA lists no recalls for product code ODS.
Frequently asked questions
What is FDA product code ODS?
ODS is the FDA product code for wound covering (composite cultured skin). It is a HDE device, reviewed by the General and Plastic Surgery panel.
What device class is ODS?
HDE. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code ODS
- Run a recall and safety report across every ODS manufacturer
- Watch product code ODS 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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