Actolind® (06.3637. Actolind® Gel Plus)— 510(k) K254168
Substantially EquivalentACTO GmbH
FDA 510(k) clearance K254168 for Actolind® (06.3637. Actolind® Gel Plus), Substantially Equivalent on 2026-09-22. Applicant: ACTO GmbH. Device class: Unclassified.
Summary
Actolind Gel Plus (06.3637) from ACTO GmbH is filed under FRO, drug-containing wound dressings. The record doesn't name any active ingredient or describe the gel's composition.
The device class is listed as U (unclassified), with no regulation number, and the advisory panel field reads Unknown. ACTO filed it as a Traditional 510(k).
ACTO filed from Braunschweig, Germany. Review took 273 days (December 23, 2025 to September 22, 2026).
Clearance details
- Applicant
- ACTO GmbH
- Product code
- Product code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Braunschweig, DE
Recent devices under product code FRO
view allAdverse events under product code FRO
product code FRO- Death
- 30
- Injury
- 653
- Malfunction
- 479
- Other
- 11
- Total
- 1,173
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.