FDA 510(k)

Vashe Plus Antimicrobial Solution

Номер K: K253665 · 2026-08-11

ЗаявительUrgo Medical North America, LLC

Дата решения2026-08-11

Код продуктаFRO

РешениеSubstantially Equivalent

Описание устройства

Vashe Plus Antimicrobial Solution is the device name listed in this FDA 510(k) record. The listed applicant is Urgo Medical North America, LLC. It received FDA 510(k) clearance on 2026-08-11 under 510(k) number K253665. 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 Vashe Plus Antimicrobial Solution?

Vashe Plus Antimicrobial Solution is a medical device that received FDA 510(k) clearance on 2026-08-11. The listed applicant is Urgo Medical North America, LLC. The 510(k) number is K253665.

When did Vashe Plus Antimicrobial Solution receive FDA 510(k) clearance?

Vashe Plus Antimicrobial Solution received FDA 510(k) clearance on 2026-08-11, under 510(k) number K253665.

Who is the listed applicant for Vashe Plus Antimicrobial Solution?

The FDA 510(k) record lists Urgo Medical North America, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vashe Plus Antimicrobial Solution?

The FDA product code for Vashe Plus Antimicrobial Solution 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)

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbH K254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.K261638Bonvadis®Oneness Biotech Co., Ltd.

Официальный источник

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