VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE VA2, VISERA CYSTO-NE— 510(k) K133538

Name: FDA 510(k) clearance K133538
Creator: U.S. Food and Drug Administration
Published: 2014-08-07

Substantially Equivalent

Olympus Corporation of the Americas

FDA 510(k) clearance K133538 for VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE VA2, VISERA CYSTO-NE, Substantially Equivalent on 2014-08-07. Applicant: Olympus Corporation of the Americas. Device class: 2.

Clearance details

Applicant: Olympus Corporation of the Americas
Product code: Code NWB
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2013-11-18
Decision date: 2014-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NWB

product code NWB

Malfunction: 12,503
Total: 12,503

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.