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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 the device name listed in this FDA 510(k) record. The listed applicant is Olympus Winter & Ibe GmbH. It received FDA 510(k) clearance on 2019-08-29 under 510(k) 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. The listed applicant is Olympus Winter & Ibe GmbH. The 510(k) number is K190744.

When did ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) receive FDA 510(k) clearance?

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

Who is the listed applicant for ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)?

The FDA 510(k) record lists Olympus Winter & Ibe GmbH as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: 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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