FDA 510(k)

Actolind® (06.3637. Actolind® Gel Plus)

Número K: K254168 · 2026-09-22

Data da decisão2026-09-22

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Fonte oficial

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