OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER— 510(k) K010591

Substantially Equivalent

Olympus Optical Co., Ltd.

FDA 510(k) clearance K010591 for OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER, Substantially Equivalent on 2001-03-15. Applicant: Olympus Optical Co., Ltd..

Clearance details

Applicant: Olympus Optical Co., Ltd.
Product code: Code ODG
Advisory panel: Gastroenterology, Urology
Date received: 2001-02-28
Decision date: 2001-03-15
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.