UPD-Y0003— 510(k) K103312

Substantially Equivalent

Olympus Medical Systems Corporation

FDA 510(k) clearance K103312 for UPD-Y0003, Substantially Equivalent on 2011-05-12. Applicant: Olympus Medical Systems Corporation.

Clearance details

Applicant: Olympus Medical Systems Corporation
Product code: Code FDF
Advisory panel: Gastroenterology, Urology
Date received: 2010-11-10
Decision date: 2011-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

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.