FDA 510(k)

RENASYS Y-Connector; RENASYS TOUCH

Número K: K181204 · 2019-01-10

RequerenteSmith & Nephew Medical Limited

Data da decisão2019-01-10

Código do produtoOMP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

RENASYS Y-Connector; RENASYS TOUCH 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 2019-01-10 under 510(k) number K181204. 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 Y-Connector; RENASYS TOUCH?

RENASYS Y-Connector; RENASYS TOUCH is a medical device that received FDA 510(k) clearance on 2019-01-10. The listed applicant is Smith & Nephew Medical Limited. The 510(k) number is K181204.

When did RENASYS Y-Connector; RENASYS TOUCH receive FDA 510(k) clearance?

RENASYS Y-Connector; RENASYS TOUCH received FDA 510(k) clearance on 2019-01-10, under 510(k) number K181204.

Who is the listed applicant for RENASYS Y-Connector; RENASYS TOUCH?

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 RENASYS Y-Connector; RENASYS TOUCH?

The FDA product code for RENASYS Y-Connector; RENASYS TOUCH is OMP.

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Fonte oficial

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