ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)— 510(k) K190744

Substantially Equivalent

Olympus Winter & Ibe GmbH

FDA 510(k) clearance K190744 for ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A), Substantially Equivalent on 2019-08-29. Applicant: Olympus Winter & Ibe GmbH.

Clearance details

Applicant: Olympus Winter & Ibe GmbH
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 2019-03-22
Decision date: 2019-08-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Hamburg, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.