FDA 510(k)

Exogenesis Hernia Mesh

Número K: K191545 · 2019-09-26

Data da decisão2019-09-26

Código do produtoFTL

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Exogenesis Hernia Mesh is the device name listed in this FDA 510(k) record. The listed applicant is Exogenesis Corporation. It received FDA 510(k) clearance on 2019-09-26 under 510(k) number K191545. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Exogenesis Hernia Mesh?

Exogenesis Hernia Mesh is a medical device that received FDA 510(k) clearance on 2019-09-26. The listed applicant is Exogenesis Corporation. The 510(k) number is K191545.

When did Exogenesis Hernia Mesh receive FDA 510(k) clearance?

Exogenesis Hernia Mesh received FDA 510(k) clearance on 2019-09-26, under 510(k) number K191545.

Who is the listed applicant for Exogenesis Hernia Mesh?

The FDA 510(k) record lists Exogenesis Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Exogenesis Hernia Mesh?

The FDA product code for Exogenesis Hernia Mesh is FTL.

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