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FDA 510(k)

Visera Elite II Video System Center, Visera Elite II Endoeye 3D

K-Number: K193026 · 2020-04-03

ApplicantOlympus Medical Systems Corp.
Decision Date2020-04-03
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Visera Elite II Video System Center, Visera Elite II Endoeye 3D is a medical device manufactured by Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2020-04-03 under approval number K193026. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Visera Elite II Video System Center, Visera Elite II Endoeye 3D?

Visera Elite II Video System Center, Visera Elite II Endoeye 3D is a medical device that received FDA 510(k) clearance on 2020-04-03. It is manufactured by Olympus Medical Systems Corp.. The 510(k) number is K193026.

When was Visera Elite II Video System Center, Visera Elite II Endoeye 3D approved by the FDA?

Visera Elite II Video System Center, Visera Elite II Endoeye 3D received FDA 510(k) clearance on 2020-04-03, under approval number K193026.

What company makes Visera Elite II Video System Center, Visera Elite II Endoeye 3D?

Visera Elite II Video System Center, Visera Elite II Endoeye 3D is manufactured by Olympus Medical Systems Corp..

What is the FDA product code for Visera Elite II Video System Center, Visera Elite II Endoeye 3D?

The FDA product code for Visera Elite II Video System Center, Visera Elite II Endoeye 3D is GCJ.

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Related PubMed Literature

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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