FDA product code SIL: Wound Dressings Containing Oxygen
SIL is the FDA product code for wound dressings containing oxygen. It is a Unclassified device, reviewed by the General and Plastic Surgery panel. Devices under SIL reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
A wound dressing containing oxygen is intended to cover and protect a wound, to absorb exudate, and to maintain appropriate moisture balance within the wound.
Classification
| Field | Value |
|---|---|
| Device name | Wound Dressings Containing Oxygen |
| Device class | Unclassified |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
Recalls for SIL devices
openFDA lists no recalls for product code SIL.
Frequently asked questions
What is FDA product code SIL?
SIL is the FDA product code for wound dressings containing oxygen. It is a Unclassified device, reviewed by the General and Plastic Surgery panel.
What device class is SIL?
Unclassified. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SIL
- Run a recall and safety report across every SIL manufacturer
- Watch product code SIL 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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