DEN250006 is an FDA 510(k) submission for the Amferia Wound Dressing. This device is classified as a Solid Wound Dressing With Permanently Bound Antimicrobial Agent (Class II - Special Controls, product code SHA).
Submitted by Amferia AB (Molndal, SE). The FDA issued a Not Cleared (DENG) decision on February 6, 2026.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4013. 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..
| 510(k) Number | DEN250006 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | March 03, 2025 |
| Decision Date | February 06, 2026 |
| Days to Decision | 340 days |
| Submission Type | Direct |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | - |
| Product Code | SHA - Solid Wound Dressing With Permanently Bound Antimicrobial Agent |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4013 |
| 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. |