FDA 510(k)

SilverStream Gel

Номер K: K200767 · 2020-10-08

Дата решения2020-10-08

Код продуктаFRO

РешениеSubstantially Equivalent

Описание устройства

SilverStream Gel is the device name listed in this FDA 510(k) record. The listed applicant is Enzysurge , Ltd.. It received FDA 510(k) clearance on 2020-10-08 under 510(k) number K200767. 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 SilverStream Gel?

SilverStream Gel is a medical device that received FDA 510(k) clearance on 2020-10-08. The listed applicant is Enzysurge , Ltd.. The 510(k) number is K200767.

When did SilverStream Gel receive FDA 510(k) clearance?

SilverStream Gel received FDA 510(k) clearance on 2020-10-08, under 510(k) number K200767.

Who is the listed applicant for SilverStream Gel?

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

What is the FDA product code for SilverStream Gel?

The FDA product code for SilverStream Gel 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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