510(k) K232997— EVIS Exera III Gastrointestinal Videoscope GIF-1TH190

Substantially Equivalent

Olympus Medical Systems Corporation

Clearance details

Applicant: Olympus Medical Systems Corporation
Product code: Code FDS
Advisory panel: Gastroenterology, Urology
Date received: 2023-09-22
Decision date: 2024-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Adverse events under product code FDS

product code FDS

Death: 37
Injury: 863
Malfunction: 56,442
Other: 1
Total: 57,343

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.