FDA 510(k)

ENDOtube

Número K: K203350 · 2021-09-29

RequerenteNissha Medical Technologies Sas

Data da decisão2021-09-29

Código do produtoOCX

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

ENDOtube is the device name listed in this FDA 510(k) record. The listed applicant is Nissha Medical Technologies Sas. It received FDA 510(k) clearance on 2021-09-29 under 510(k) number K203350. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ENDOtube?

ENDOtube is a medical device that received FDA 510(k) clearance on 2021-09-29. The listed applicant is Nissha Medical Technologies Sas. The 510(k) number is K203350.

When did ENDOtube receive FDA 510(k) clearance?

ENDOtube received FDA 510(k) clearance on 2021-09-29, under 510(k) number K203350.

Who is the listed applicant for ENDOtube?

The FDA 510(k) record lists Nissha Medical Technologies Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDOtube?

The FDA product code for ENDOtube is OCX.

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