510(k) K254168
K254168 is an FDA 510(k) premarket notification submitted by ACTO GmbH for the device "Actolind® (06.3637. Actolind® Gel Plus)". The FDA issued a decision of Substantially Equivalent on Sep 22, 2026. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 22, 2026
- Date Received
- Dec 23, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Drug
- Device Class
- Class U
- Review Panel
- SU
- Submission Type
- 510(k)