K222861

Substantially Equivalent

EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100

Applicant: Olympus Medical Systems Corporation
Product code: EOQ
Advisory panel: Ear, Nose, Throat
Date received: 2022-09-22
Decision date: 2023-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

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.