FDA 510(k)

PICO 14 Single Use Negative Pressure Wound Therapy System

Número K: K191760 · 2019-12-05

RequerenteSmith & Nephew Medical Limited

Data da decisão2019-12-05

Código do produtoOMP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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Outros registros que listam Smith & Nephew Medical Limited como candidato(a)

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Dispositivos Relacionados (Código: OMP)

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Fonte oficial

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