FDA 510(k)

LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel

N.º K: K211123 · 2022-04-22

SolicitanteHuizhou Foryou Medical Devices Co., Ltd.

Fecha de decisión2022-04-22

Código de productoFRO

DecisiónSubstantially Equivalent

Resumen del dispositivo

LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel is the device name listed in this FDA 510(k) record. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2022-04-22 under 510(k) number K211123. 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.

Preguntas frecuentes

What is the LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel?

LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel is a medical device that received FDA 510(k) clearance on 2022-04-22. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. The 510(k) number is K211123.

When did LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel receive FDA 510(k) clearance?

LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel received FDA 510(k) clearance on 2022-04-22, under 510(k) number K211123.

Who is the listed applicant for LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel?

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

What is the FDA product code for LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel?

The FDA product code for LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel is FRO. This falls under the Anesthesiology category.

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Otros registros que enlistan a Huizhou Foryou Medical Devices Co., Ltd. como solicitante

K254256LUOFUCON® Wound Matrix K250642LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)K240809LUOFUCON® Silver Collagen Dressing K242856LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)K240485LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use)K232796LUOFUCON® Collagen Particles (Collagen Wound Dressing)

Ver todos los 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.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.