K011886

Substantially Equivalent

OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160,

Applicant: Olympus America, Inc.
Product code: ODG
Advisory panel: Gastroenterology, Urology
Date received: 2001-06-15
Decision date: 2001-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, US

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.