VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V— 510(k) K022445

Substantially Equivalent

Olympus Optical Co., Ltd.

FDA 510(k) clearance K022445 for VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V, Substantially Equivalent on 2003-01-24. Applicant: Olympus Optical Co., Ltd..

Clearance details

Applicant: Olympus Optical Co., Ltd.
Product code: Code HIH
Advisory panel: Obstetrics/Gynecology
Date received: 2002-07-25
Decision date: 2003-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIH

product code HIH

Death: 18
Injury: 973
Malfunction: 5,071
Other: 1
Total: 6,063

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.