EZC · Class II · 21 CFR 876.5130

FDA Product Code EZC: Catheter, Coude

Leading manufacturers include C.R. Bard, Inc. and Teleflex Medical.

7
Total
7
Cleared
137d
Avg days
1991
Since
Stable submission activity - 0 submissions in the last 2 years

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

7 devices
1–7 of 7
Cleared Aug 29, 2022
Rusch Intermittent Urethral Catheters
K222279
Teleflex Medical
Gastroenterology & Urology · 31d
Cleared Jan 29, 2018
Rusch Intermittent Urethral Catheters
K173596
Teleflex Medical
Gastroenterology & Urology · 69d
Cleared Jan 27, 1992
BARD(R) COUDE TIP TEMPERATURE SENSING CATHETER
K913341
C.R. Bard, Inc.
Gastroenterology & Urology · 185d
Cleared Aug 16, 1991
BARD LATEX URINARY CATHETERS DRAINS- DESIGNS MODIF
K910846
C.R. Bard, Inc.
Gastroenterology & Urology · 170d
Cleared Aug 09, 1991
BARD HYDROGEL-COATED FOLEY CATHETERS
K910195
C.R. Bard, Inc.
Gastroenterology & Urology · 205d
Cleared Aug 09, 1991
HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS
K910197
C.R. Bard, Inc.
Gastroenterology & Urology · 205d

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 remained relatively stable over the observed period, with 0 submissions in the last 24 months.