510(k) K071254— SMALL INTESTINAL VIDEOSCOPE SYSTEM

Substantially Equivalent

Olympus Medical Systems Corporation

Clearance details

Applicant: Olympus Medical Systems Corporation
Product code: Code FDA
Advisory panel: Gastroenterology, Urology
Date received: 2007-05-04
Decision date: 2008-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

Adverse events under product code FDA

product code FDA

Death: 8
Injury: 148
Total: 156

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.