FDA 510(k)

RENASYS GO

Número K: K152163 · 2016-09-29

Data da decisão2016-09-29

Código do produtoOMP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

RENASYS GO is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2016-09-29 under 510(k) number K152163. 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 RENASYS GO?

RENASYS GO is a medical device that received FDA 510(k) clearance on 2016-09-29. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K152163.

When did RENASYS GO receive FDA 510(k) clearance?

RENASYS GO received FDA 510(k) clearance on 2016-09-29, under 510(k) number K152163.

Who is the listed applicant for RENASYS GO?

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

What is the FDA product code for RENASYS GO?

The FDA product code for RENASYS GO is OMP.

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