FDA 510(k)

PICO Single Use Negative Pressure Wound Therapy System

N.º K: K163387 · 2017-04-18

SolicitanteSmith & Nephew Medical Limited

Fecha de decisión2017-04-18

Código de productoOMP

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

PICO 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 2017-04-18 under 510(k) number K163387. 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 Single Use Negative Pressure Wound Therapy System?

PICO Single Use Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2017-04-18. The listed applicant is Smith & Nephew Medical Limited. The 510(k) number is K163387.

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

PICO Single Use Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2017-04-18, under 510(k) number K163387.

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

The FDA product code for PICO 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

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.