FDA 510(k)

ViziShot 2 FLEX

Número K: K193517 · 2020-03-18

RequerenteOlympus Surgical Technologies America

Data da decisão2020-03-18

Código do produtoKTI

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

ViziShot 2 FLEX is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Surgical Technologies America. It received FDA 510(k) clearance on 2020-03-18 under 510(k) number K193517. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ViziShot 2 FLEX?

ViziShot 2 FLEX is a medical device that received FDA 510(k) clearance on 2020-03-18. The listed applicant is Olympus Surgical Technologies America. The 510(k) number is K193517.

When did ViziShot 2 FLEX receive FDA 510(k) clearance?

ViziShot 2 FLEX received FDA 510(k) clearance on 2020-03-18, under 510(k) number K193517.

Who is the listed applicant for ViziShot 2 FLEX?

The FDA 510(k) record lists Olympus Surgical Technologies America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ViziShot 2 FLEX?

The FDA product code for ViziShot 2 FLEX is KTI.

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