ENDOEYE HD II— 510(k) K111788

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K111788 for ENDOEYE HD II, Substantially Equivalent on 2012-01-13. Applicant: Olympus America, Inc..

Clearance details

Applicant: Olympus America, Inc.
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 2011-06-24
Decision date: 2012-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

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.