Clearance Summary
Amferia Wound Dressing received FDA 510(k) clearance under submission number DEN250006, sponsored by Amferia AB. The device was reviewed via the Direct premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2026-02-06.
- Submission: DEN250006
- Applicant / Sponsor: Amferia AB
- Clearance pathway: Direct
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4013
- Decision date: 2026-02-06
Classification & Regulation
This clearance is catalogued under FDA product code SHA and 21 CFR 878.4013, within the General, Plastic Surgery review panel as a Class II device.