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FDA 510(k)

ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)

K-Number: K190744 · 2019-08-29

ApplicantOlympus Winter & Ibe GmbH
Decision Date2019-08-29
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) is a medical device manufactured by Olympus Winter & Ibe GmbH. It received FDA 510(k) clearance on 2019-08-29 under approval number K190744. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)?

ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) is a medical device that received FDA 510(k) clearance on 2019-08-29. It is manufactured by Olympus Winter & Ibe GmbH. The 510(k) number is K190744.

When was ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) approved by the FDA?

ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) received FDA 510(k) clearance on 2019-08-29, under approval number K190744.

What company makes ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)?

ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) is manufactured by Olympus Winter & Ibe GmbH.

What is the FDA product code for ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)?

The FDA product code for ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) is HET.

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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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