510(k) K254168 · FRO Dressing, Wound, Drug
Actolind® (06.3637. Actolind® Gel Plus)
| Applicant | ACTO GmbH, Braunschweig, DE |
| Decision | Substantially Equivalent, Sep 22, 2026 |
| Received | Dec 23, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254168
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.