FDA 510(k)

PeriView FLEX

Número K: K171232 · 2017-09-21

RequerenteOlympus Surgical Technologies America

Data da decisão2017-09-21

Código do produtoKTI

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

PeriView 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 2017-09-21 under 510(k) number K171232. 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 PeriView FLEX?

PeriView FLEX is a medical device that received FDA 510(k) clearance on 2017-09-21. The listed applicant is Olympus Surgical Technologies America. The 510(k) number is K171232.

When did PeriView FLEX receive FDA 510(k) clearance?

PeriView FLEX received FDA 510(k) clearance on 2017-09-21, under 510(k) number K171232.

Who is the listed applicant for PeriView 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 PeriView FLEX?

The FDA product code for PeriView FLEX is KTI.

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