510(k) DEN250006
DEN250006 is an FDA 510(k) premarket notification submitted by Amferia AB for the device "Amferia Wound Dressing". The FDA issued a decision of De Novo Granted on Feb 6, 2026. The device falls under product code SHA (Solid Wound Dressing With Permanently Bound Antimicrobial Agent), a Class II device regulated under 21 CFR 878.4013.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- Feb 6, 2026
- Date Received
- Mar 3, 2025
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Solid Wound Dressing With Permanently Bound Antimicrobial Agent
- Device Class
- Class II
- Regulation Number
- 878.4013
- Review Panel
- SU
- Submission Type
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.