FDA 510(k)

Desinfetante Antibacteriano para Curativo de Ferimento

Número K: K231057 · 2023-12-01

Data da decisão2023-12-01

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Antibacterial Gel Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Winner Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-12-01 under 510(k) number K231057. 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 Antibacterial Gel Wound Dressing?

Antibacterial Gel Wound Dressing is a medical device that received FDA 510(k) clearance on 2023-12-01. The listed applicant is Winner Medical Co., Ltd.. The 510(k) number is K231057.

When did Antibacterial Gel Wound Dressing receive FDA 510(k) clearance?

Antibacterial Gel Wound Dressing received FDA 510(k) clearance on 2023-12-01, under 510(k) number K231057.

Who is the listed applicant for Antibacterial Gel Wound Dressing?

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

What is the FDA product code for Antibacterial Gel Wound Dressing?

The FDA product code for Antibacterial Gel Wound Dressing is FRO. This falls under the Anesthesiology category.

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Outros registros que listam Winner Medical Co., Ltd. como candidato(a)

K252001Collagen Wound Dressing K250082Procedure mask/Surgical mask/Face mask K231564Skin and Wound Cleanser K231152Collagen Wound Dressing K221311Bandagem Antibacteriana K223232Procedure mask/Surgical mask/Face mask

Ver todos os 18 dispositivos →

Dispositivos Relacionados (Código: 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.

Fonte oficial

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