UroGen Ureteral Catheter— 510(k) K180354

Substantially Equivalent

Urogen Pharma, Ltd.

FDA 510(k) clearance K180354 for UroGen Ureteral Catheter, Substantially Equivalent on 2018-10-30. Applicant: Urogen Pharma, Ltd..

Clearance details

Applicant: Urogen Pharma, Ltd.
Product code: Code KOD
Advisory panel: Gastroenterology, Urology
Date received: 2018-02-08
Decision date: 2018-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: RaAnana, 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, 2020-01-01 through 2026-04-23. 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.