EZC · Class II · 21 CFR 876.5130

FDA Product Code EZC: Catheter, Coude

Leading manufacturers include Teleflex Medical.

7
Total
7
Cleared
137d
Avg days
1991
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Catheter, Coude Devices (Product Code EZC)

7 devices
1–7 of 7

About Product Code EZC - Regulatory Context

510(k) Submission Activity

7 total 510(k) submissions under product code EZC since 1991, with 7 receiving FDA clearance (average review time: 137 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

EZC devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →