EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)— 510(k) K251859

Substantially Equivalent

Olympus Medical Systems Corporation

FDA 510(k) clearance K251859 for EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190), Substantially Equivalent on 2025-10-03. Applicant: Olympus Medical Systems Corporation.

Clearance details

Applicant: Olympus Medical Systems Corporation
Product code: Code ODG
Advisory panel: Gastroenterology, Urology
Date received: 2025-06-17
Decision date: 2025-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code ODG

product code ODG

Death: 30
Injury: 237
Malfunction: 12,387
Other: 1
Total: 12,655

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.