K192664

Substantially Equivalent

FUJIFILM Endoscope Model EC-760Z-V/L

Applicant: Fujifilm Corporation
Product code: FDF
Advisory panel: Gastroenterology, Urology
Date received: 2019-09-25
Decision date: 2019-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ashigara Kami-Gun, JP

Adverse events under product code FDF

product code FDF

Death: 8
Injury: 729
Malfunction: 61,773
Total: 62,510

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.