FDA 510(k)

PICO Single Use Negative Pressure Wound Therapy System

Número K: K151436 · 2016-01-28

Data da decisão2016-01-28

Código do produtoOMP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do 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, Ltd.. It received FDA 510(k) clearance on 2016-01-28 under 510(k) number K151436. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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 2016-01-28. The listed applicant is Smith & Nephew Medical, Ltd.. The 510(k) number is K151436.

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 2016-01-28, under 510(k) number K151436.

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

The FDA 510(k) record lists Smith & Nephew Medical, Ltd. 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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Dispositivos Relacionados (Código: OMP)

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Fonte oficial

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