FDA Product Code EZN: Dilator, Catheter, Ureteral
Leading manufacturers include Urotronic, Inc..
FDA 510(k) Cleared Dilator, Catheter, Ureteral Devices (Product Code EZN)
About Product Code EZN - Regulatory Context
510(k) Submission Activity
56 total 510(k) submissions under product code EZN since 1981, with 56 receiving FDA clearance (average review time: 106 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under EZN have taken an average of 57 days to reach a decision - down from 107 days historically, suggesting improved FDA processing for this classification.
EZN devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →