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)
About Product Code SHA - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SHA since 2026, with 0 receiving FDA clearance (average review time: 340 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SHA devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →