DeviceClearance

K053410

Substantially Equivalent

GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR

Applicant
Kendall
Product code
FEG
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mansfield, MA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FEG

product code FEG
Death
2
Total
2

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.