FDA 510(k)

PeriView FLEX

N.º K: K181193 · 2018-07-03

SolicitanteOlympus Surgical Technologies America

Fecha de decisión2018-07-03

Código de productoKTI

Comité asesorEN

DecisiónSubstantially Equivalent

Resumen del 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 2018-07-03 under 510(k) number K181193. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the PeriView FLEX?

PeriView FLEX is a medical device that received FDA 510(k) clearance on 2018-07-03. The listed applicant is Olympus Surgical Technologies America. The 510(k) number is K181193.

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

PeriView FLEX received FDA 510(k) clearance on 2018-07-03, under 510(k) number K181193.

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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Fuente oficial

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