DeviceClearance

K041494

Substantially Equivalent

OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2

Applicant
Olympus Corporation
Product code
FET
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Melville, NY, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FET

product code FET
Injury
313
Malfunction
54,276
Total
54,589

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.