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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 the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2020-04-03 under 510(k) 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. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K193026.

When did Visera Elite II Video System Center, Visera Elite II Endoeye 3D receive FDA 510(k) clearance?

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

Who is the listed applicant for Visera Elite II Video System Center, Visera Elite II Endoeye 3D?

The FDA 510(k) record lists Olympus Medical Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

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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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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