FDA 510(k)

PICO 14 Single Use Negative Pressure Wound Therapy System

N.º K: K191760 · 2019-12-05

SolicitanteSmith & Nephew Medical Limited

Fecha de decisión2019-12-05

Código de productoOMP

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

PICO 14 Single Use Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Medical Limited. It received FDA 510(k) clearance on 2019-12-05 under 510(k) number K191760. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the PICO 14 Single Use Negative Pressure Wound Therapy System?

PICO 14 Single Use Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2019-12-05. The listed applicant is Smith & Nephew Medical Limited. The 510(k) number is K191760.

When did PICO 14 Single Use Negative Pressure Wound Therapy System receive FDA 510(k) clearance?

PICO 14 Single Use Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2019-12-05, under 510(k) number K191760.

Who is the listed applicant for PICO 14 Single Use Negative Pressure Wound Therapy System?

The FDA 510(k) record lists Smith & Nephew Medical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PICO 14 Single Use Negative Pressure Wound Therapy System?

The FDA product code for PICO 14 Single Use Negative Pressure Wound Therapy System is OMP.

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Otros registros que enlistan a Smith & Nephew Medical Limited como solicitante

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Dispositivos relacionados (Código: OMP)

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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.