EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V— 510(k) K143153

Substantially Equivalent

Olympus Medical Systems Corp.

FDA 510(k) clearance K143153 for EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V, Substantially Equivalent on 2016-01-15. Applicant: Olympus Medical Systems Corp..

Clearance details

Applicant: Olympus Medical Systems Corp.
Product code: Code FDT
Advisory panel: Gastroenterology, Urology
Date received: 2014-11-03
Decision date: 2016-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hachioji-Shi, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code FDT

product code FDT

Death: 86
Injury: 1,954
Malfunction: 14,912
Total: 16,952

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.