Rhino-Laryngo Videoscope Olympus ENF-VT3— 510(k) K183416

Substantially Equivalent

Olympus Medical Systems Corp.

FDA 510(k) clearance K183416 for Rhino-Laryngo Videoscope Olympus ENF-VT3, Substantially Equivalent on 2019-09-06. Applicant: Olympus Medical Systems Corp..

Clearance details

Applicant: Olympus Medical Systems Corp.
Product code: Code EOB
Advisory panel: Ear, Nose, Throat
Date received: 2018-12-10
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 EOB

product code EOB

Malfunction: 6,143
Total: 6,143

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.