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FDA 510(k)

AGRX Limpieza de Heridas Antibacteriana de Silver para la Piel y las Heridas (Rx) y AGX Limpieza de Piel y Heridas (OTC)

N.º K: K151185 · 2016-02-05

SolicitanteAbl Medical, LLC
Fecha de decisión2016-02-05
Código de productoFRO
DecisiónSubstantially Equivalent

Resumen del dispositivo

AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC) is the device name listed in this FDA 510(k) record. The listed applicant is Abl Medical, LLC. It received FDA 510(k) clearance on 2016-02-05 under 510(k) number K151185. 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 AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC)?

AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC) is a medical device that received FDA 510(k) clearance on 2016-02-05. The listed applicant is Abl Medical, LLC. The 510(k) number is K151185.

When did AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC) receive FDA 510(k) clearance?

AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC) received FDA 510(k) clearance on 2016-02-05, under 510(k) number K151185.

Who is the listed applicant for AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC)?

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

What is the FDA product code for AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC)?

The FDA product code for AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC) is FRO. This falls under the Anesthesiology category.

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Dispositivos relacionados (Código: FRO)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

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

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