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FDA 510(k)

Actolind® (06.3637. Actolind® Gel Plus)

K-Number: K254168 · 2026-09-22

ApplicantACTO GmbH
Decision Date2026-09-22
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Actolind® (06.3637. Actolind® Gel Plus) is the device name listed in this FDA 510(k) record. The listed applicant is ACTO GmbH. It received FDA 510(k) clearance on 2026-09-22 under 510(k) number K254168. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Actolind® (06.3637. Actolind® Gel Plus)?

Actolind® (06.3637. Actolind® Gel Plus) is a medical device that received FDA 510(k) clearance on 2026-09-22. The listed applicant is ACTO GmbH. The 510(k) number is K254168.

When did Actolind® (06.3637. Actolind® Gel Plus) receive FDA 510(k) clearance?

Actolind® (06.3637. Actolind® Gel Plus) received FDA 510(k) clearance on 2026-09-22, under 510(k) number K254168.

Who is the listed applicant for Actolind® (06.3637. Actolind® Gel Plus)?

The FDA 510(k) record lists ACTO GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Actolind® (06.3637. Actolind® Gel Plus)?

The FDA product code for Actolind® (06.3637. Actolind® Gel Plus) is FRO. This falls under the Anesthesiology category.

Related Devices (Code: FRO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261638Bonvadis®Oneness Biotech Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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