RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4— 510(k) K182102

Substantially Equivalent

Olympus Medical Systems Corp.

FDA 510(k) clearance K182102 for RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4, Substantially Equivalent on 2019-02-06. Applicant: Olympus Medical Systems Corp..

Clearance details

Applicant: Olympus Medical Systems Corp.
Product code: Code EOB
Advisory panel: Ear, Nose, Throat
Date received: 2018-08-03
Decision date: 2019-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hachioji-Shi, JP

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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.