FDA 510(k)

Anexa Wound Flush, Agua Estéril y Salina Normal Estéril

N.º K: K161658 · 2016-09-14

Fecha de decisión2016-09-14

Código de productoFRO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Anexa Wound Flush, Sterile Water & Sterile Normal Saline is the device name listed in this FDA 510(k) record. The listed applicant is Anexa Biomedical, Inc.. It received FDA 510(k) clearance on 2016-09-14 under 510(k) number K161658. 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 Anexa Wound Flush, Sterile Water & Sterile Normal Saline?

Anexa Wound Flush, Sterile Water & Sterile Normal Saline is a medical device that received FDA 510(k) clearance on 2016-09-14. The listed applicant is Anexa Biomedical, Inc.. The 510(k) number is K161658.

When did Anexa Wound Flush, Sterile Water & Sterile Normal Saline receive FDA 510(k) clearance?

Anexa Wound Flush, Sterile Water & Sterile Normal Saline received FDA 510(k) clearance on 2016-09-14, under 510(k) number K161658.

Who is the listed applicant for Anexa Wound Flush, Sterile Water & Sterile Normal Saline?

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

What is the FDA product code for Anexa Wound Flush, Sterile Water & Sterile Normal Saline?

The FDA product code for Anexa Wound Flush, Sterile Water & Sterile Normal Saline is FRO. This falls under the Anesthesiology category.

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Otros registros que enlistan a Anexa Biomedical, Inc. como solicitante

K172486Anexa Wound Flush, Agua Estéril USP, y Salina Normal Estéril USP (cloruro de sodio al 0.9%) 120 mL taza, Agua Estéril USP, y Salina Normal Estéril USP (cloruro de sodio al 0.9%) 100 mL botella, Agua Estéril USP, y Salina Normal Estéril USP (cloruro de sodio al 0.9%) 250 mL botella, Agua Estéril USP, y Salina Normal Estéril USP (cloruro de sodio al 0.9%) 500 mL botella

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

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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.