DeviceClearance

K180354

Substantially Equivalent

UroGen Ureteral Catheter

Applicant
Urogen Pharma, Ltd.
Product code
KOD
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ra’Anana, IL
Download summary PDF View on FDA.gov ↗

Adverse events under product code KOD

product code KOD
Death
5
Injury
1,129
Malfunction
7,019
Total
8,153

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.