K131780

Substantially Equivalent

EVIS EXERA III VIDEO SYSTEM

Applicant: Olympus Medical Systems Corp.
Product code: FDF
Advisory panel: Gastroenterology, Urology
Date received: 2013-06-17
Decision date: 2013-08-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Center Valley, PA, US

Adverse events under product code FDF

product code FDF

Death: 8
Injury: 729
Malfunction: 61,773
Total: 62,510

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.