510(k) clearance
Actolind® (06.3637. Actolind® Gel Plus)
- 510(k) number
- K254168
- Applicant
- ACTO GmbH
- Decision date
- Sep 22, 2026
- Date received
- Dec 23, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- FRO
- Device type
- Dressing, Wound, Drug
- Device class
- Unclassified
- Advisory committee
- Unknown
- Statement or summary
- Summary
- Third party
- N
- Location
- Braunschweig, DE