FDA 510(k)

MedicloseTM System

Número K: K213271 · 2023-08-31

RequerenteHealth Value Creation B.V., Trading AS Corporis Medical

Data da decisão2023-08-31

Código do produtoOCW

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

MedicloseTM System is the device name listed in this FDA 510(k) record. The listed applicant is Health Value Creation B.V., Trading AS Corporis Medical. It received FDA 510(k) clearance on 2023-08-31 under 510(k) number K213271. The device is classified under product code OCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MedicloseTM System?

MedicloseTM System is a medical device that received FDA 510(k) clearance on 2023-08-31. The listed applicant is Health Value Creation B.V., Trading AS Corporis Medical. The 510(k) number is K213271.

When did MedicloseTM System receive FDA 510(k) clearance?

MedicloseTM System received FDA 510(k) clearance on 2023-08-31, under 510(k) number K213271.

Who is the listed applicant for MedicloseTM System?

The FDA 510(k) record lists Health Value Creation B.V., Trading AS Corporis Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MedicloseTM System?

The FDA product code for MedicloseTM System is OCW.

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