VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA— 510(k) K021074

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K021074 for VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA, Substantially Equivalent on 2002-05-02. Applicant: Olympus America, Inc..

Clearance details

Applicant: Olympus America, Inc.
Product code: Code FAJ
Advisory panel: Gastroenterology, Urology
Date received: 2002-04-02
Decision date: 2002-05-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Melville, NY, US

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Adverse events under product code FAJ

product code FAJ

Injury: 533
Malfunction: 6,705
Total: 7,238

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.