FDA 510(k)

RENASYS-G Gauze Dressing Kits with Soft Port

Número K: K162129 · 2016-08-31

Data da decisão2016-08-31

Código do produtoOMP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

RENASYS-G Gauze Dressing Kits with Soft Port 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 2016-08-31 under 510(k) number K162129. 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-G Gauze Dressing Kits with Soft Port?

RENASYS-G Gauze Dressing Kits with Soft Port is a medical device that received FDA 510(k) clearance on 2016-08-31. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K162129.

When did RENASYS-G Gauze Dressing Kits with Soft Port receive FDA 510(k) clearance?

RENASYS-G Gauze Dressing Kits with Soft Port received FDA 510(k) clearance on 2016-08-31, under 510(k) number K162129.

Who is the listed applicant for RENASYS-G Gauze Dressing Kits with Soft Port?

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-G Gauze Dressing Kits with Soft Port?

The FDA product code for RENASYS-G Gauze Dressing Kits with Soft Port is OMP.

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