FDA product code SHA: Solid Wound Dressing With Permanently Bound Antimicrobial Agent
SHA is the FDA product code for solid wound dressing with permanently bound antimicrobial agent. It is a Class II device, regulated under 21 CFR 878.4013 and reviewed by the General and Plastic Surgery panel. Devices under SHA reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A solid wound dressing with permanently bound antimicrobial agent consists of a solid wound dressing containing antimicrobial permanently bound to the substrate surface. The solid wound dressing is used to cover and protect a wound, to absorb exudate, and to maintain appropriate moisture balance within the wound and is intended for use only on external cutaneous (skin) wounds. The solid wound dressing is provided sterile in a form able to hold structural integrity. Antimicrobials are used for protectant purposes only to reduce microbial growth within the solid wound dressing while in use, or to provide an antimicrobial barrier to microbial penetration through the solid wound dressing. This classification does not include solid wound dressings containing a medically important antimicrobial as defined in the special controls.
Classification
| Field | Value |
|---|---|
| Device name | Solid Wound Dressing With Permanently Bound Antimicrobial Agent |
| Device class | Class II |
| Regulation | 21 CFR 878.4013 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
Recalls for SHA devices
openFDA lists no recalls for product code SHA.
Frequently asked questions
What is FDA product code SHA?
SHA is the FDA product code for solid wound dressing with permanently bound antimicrobial agent. It is a Class II device, regulated under 21 CFR 878.4013 and reviewed by the General and Plastic Surgery panel.
What device class is SHA?
Class II, regulation 21 CFR 878.4013. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SHA
- Run a recall and safety report across every SHA manufacturer
- Watch product code SHA 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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