DeviceClearance

K221952

Substantially Equivalent

Endoscope Model EG-580UT and Endoscope Model EG-580UR

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

Adverse events under product code ODG

product code ODG
Death
30
Injury
237
Malfunction
12,387
Other
1
Total
12,655

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.