FDA Product Code SHA: Solid Wound Dressing With Permanently Bound Antimicrobial Agent
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.
Leading manufacturers include Amferia AB.
FDA 510(k) Cleared Solid Wound Dressing With Permanently Bound Antimicrobial Agent Devices (Product Code SHA)
How to use this database
This page lists all FDA 510(k) submissions for Solid Wound Dressing With Permanently Bound Antimicrobial Agent devices (product code SHA). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the General & Plastic Surgery FDA review panel. Browse all General & Plastic Surgery devices →