510(k) K180341— FUJIFILM 600 Series Endoscope EG-600WR v2

Substantially Equivalent

Fujifilm Corporation

Clearance details

Applicant: Fujifilm Corporation
Product code: Code FDS
Advisory panel: Gastroenterology, Urology
Date received: 2018-02-07
Decision date: 2018-08-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Ashigara Kami-Gun, JP

Adverse events under product code FDS

product code FDS

Death: 37
Injury: 863
Malfunction: 56,442
Other: 1
Total: 57,343

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.