DeviceClearance

K240142

Substantially Equivalent

FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP

Applicant
Fujifilm Corporation
Product code
FDS
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ashigara Kami-Gun, JP
Download summary PDF View on FDA.gov ↗

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, through . 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.