FDA 510(k)

Actolind® (06.3637. Actolind® Gel Plus)

Номер K: K254168 · 2026-09-22

ЗаявительACTO GmbH

Дата решения2026-09-22

Код продуктаFRO

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: FRO)

K254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.K261638Bonvadis®Oneness Biotech Co., Ltd.

Официальный источник

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