EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F— 510(k) K183525

Substantially Equivalent

Olympus Medical Systems Corp.

FDA 510(k) clearance K183525 for EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F, Substantially Equivalent on 2019-09-06. Applicant: Olympus Medical Systems Corp..

Clearance details

Applicant: Olympus Medical Systems Corp.
Product code: Code PSV
Advisory panel: Radiology
Date received: 2018-12-19
Decision date: 2019-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hachioji-Shi, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code PSV

product code PSV

Death: 6
Injury: 305
Malfunction: 3,705
Total: 4,016

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.