Visera Elite II Video System Center— 510(k) K201200

Substantially Equivalent

Olympus Medical Systems Corp.

FDA 510(k) clearance K201200 for Visera Elite II Video System Center, Substantially Equivalent on 2020-07-22. Applicant: Olympus Medical Systems Corp..

Clearance details

Applicant: Olympus Medical Systems Corp.
Product code: Code FET
Advisory panel: Gastroenterology, Urology
Date received: 2020-05-04
Decision date: 2020-07-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Hachioji-Shi, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code FET

product code FET

Injury: 313
Malfunction: 54,276
Total: 54,589

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.