Cleared Special

K190744 - ENDOEYE HD II (WA50040A

K190744 is the FDA 510(k) clearance for ENDOEYE HD II (WA50040A by Olympus Winter & Ibe GmbH. It is a Class 2 Obstetrics & Gynecology device (product code HET) cleared through the Special 510(k) pathway after a 160-day FDA review.

K190744 · Olympus Winter & Ibe GmbH · Obstetrics & Gynecology device
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Aug 2019
Decision
160d
Days
Class 2
Risk

K190744 is an FDA 510(k) clearance for the ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A). Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Olympus Winter & Ibe GmbH (Hamburg, DE). The FDA issued a Cleared decision on August 29, 2019 after a review of 160 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Olympus Winter & Ibe GmbH devices

Submission Details

510(k) Number K190744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2019
Decision Date August 29, 2019
Days to Decision 160 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 160d · This submission: 160d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Consultant

Olympus Corporation of the Americas
Sheri L Musgnung

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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