EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT— 510(k) K033225

Substantially Equivalent

Olympus Optical Co., Ltd.

FDA 510(k) clearance K033225 for EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT, Substantially Equivalent on 2003-10-16. Applicant: Olympus Optical Co., Ltd..

Clearance details

Applicant: Olympus Optical Co., Ltd.
Product code: Code EOQ
Advisory panel: Ear, Nose, Throat
Date received: 2003-10-06
Decision date: 2003-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, US

Download summary PDF View on FDA.gov ↗

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.