Urogen Pharma, Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Urinary Catheter 12 Fr, Urinary Catheter 16 Fr, Cystoject Syringe Lever, Uroject12 Syringe Lever
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Urogen Pharma, Ltd. Gastroenterology & Urology ✕
5 devices
Cleared
Nov 19, 2021
Urinary Catheter 12 Fr, Urinary Catheter 16 Fr
Gastroenterology & Urology
226d
Cleared
Dec 09, 2020
Cystoject Syringe Lever
Gastroenterology & Urology
27d
Cleared
Dec 02, 2019
Uroject12 Syringe Lever
Gastroenterology & Urology
231d
Cleared
Oct 30, 2018
UroGen Ureteral Catheter
Gastroenterology & Urology
264d
Cleared
Oct 17, 2018
Uroject12 Syringe Lever
Gastroenterology & Urology
251d