K050220

Substantially Equivalent

EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC

Applicant: Olympus Medical Systems Corporation
Product code: EOQ
Advisory panel: Ear, Nose, Throat
Date received: 2005-01-31
Decision date: 2005-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, US

Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

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.