Urinary Catheter 12 Fr, Urinary Catheter 16 Fr— 510(k) K211032

Substantially Equivalent

Urogen Pharma, Ltd.

FDA 510(k) clearance K211032 for Urinary Catheter 12 Fr, Urinary Catheter 16 Fr, Substantially Equivalent on 2021-11-19. Applicant: Urogen Pharma, Ltd..

Clearance details

Applicant: Urogen Pharma, Ltd.
Product code: Code KOD
Advisory panel: Gastroenterology, Urology
Date received: 2021-04-07
Decision date: 2021-11-19
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, 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.