Visera Elite II Video System Center, Visera Elite II Endoeye 3D— 510(k) K193026

Substantially Equivalent

Olympus Medical Systems Corp.

FDA 510(k) clearance K193026 for Visera Elite II Video System Center, Visera Elite II Endoeye 3D, Substantially Equivalent on 2020-04-03. Applicant: Olympus Medical Systems Corp..

Clearance details

Applicant: Olympus Medical Systems Corp.
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2019-10-30
Decision date: 2020-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hachioji-Shi, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

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.