FDA 510(k)

MiraChlor Antimicrobial Wound Solution

Номер K: K252023 · 2026-03-25

Дата решения2026-03-25

Код продуктаFRO

РешениеSubstantially Equivalent

Описание устройства

MiraChlor Antimicrobial Wound Solution is the device name listed in this FDA 510(k) record. The listed applicant is Letus Corporation. It received FDA 510(k) clearance on 2026-03-25 under 510(k) number K252023. 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 MiraChlor Antimicrobial Wound Solution?

MiraChlor Antimicrobial Wound Solution is a medical device that received FDA 510(k) clearance on 2026-03-25. The listed applicant is Letus Corporation. The 510(k) number is K252023.

When did MiraChlor Antimicrobial Wound Solution receive FDA 510(k) clearance?

MiraChlor Antimicrobial Wound Solution received FDA 510(k) clearance on 2026-03-25, under 510(k) number K252023.

Who is the listed applicant for MiraChlor Antimicrobial Wound Solution?

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

What is the FDA product code for MiraChlor Antimicrobial Wound Solution?

The FDA product code for MiraChlor Antimicrobial Wound 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.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.

Официальный источник

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