EZN · Class II · 21 CFR 876.5470

FDA Product Code EZN: Dilator, Catheter, Ureteral

Leading manufacturers include Boston Scientific Corp, Cook Incorporated and C.R. Bard, Inc..

56
Total
56
Cleared
106d
Avg days
1981
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg 57d recently vs 107d historically

FDA 510(k) Cleared Dilator, Catheter, Ureteral Devices (Product Code EZN)

56 devices
1–24 of 56
Cleared May 22, 2025
Optilume® High Pressure Urological Balloon Dilation Catheter
K250910
Urotronic, Inc.
Gastroenterology & Urology · 57d
Cleared May 05, 2023
ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter
K220781
Allwin Medical Devices, Inc.
Gastroenterology & Urology · 414d
Cleared Jun 11, 2020
In-Ka Ureteral Balloon Dilatation Catheter
K201007
Coloplast Corp.
Gastroenterology & Urology · 55d
Cleared Dec 06, 2019
EQUINOX Balloon Dilatation Catheter
K190612
Dornier Medtech America, Inc.
Gastroenterology & Urology · 270d
Cleared Jul 17, 2018
Ureteral Dilator Sets, Ureteral Dilators
K173654
Cook Incorporated
Gastroenterology & Urology · 231d
Cleared May 24, 2018
Safety Wire Guide Introducer
K180756
Cook Incorporated
Gastroenterology & Urology · 63d
Cleared May 02, 2018
Cook 810 Set, Desilets-Hoffman Introducer Set
K180028
Cook Incorporated
Gastroenterology & Urology · 119d
Cleared Apr 19, 2018
Balloon Catheter and Balloon Ureteral Dilator Set
K172588
Cook Incorporated
Gastroenterology & Urology · 233d
Cleared May 22, 2013
UROMAX ULTRA BALLOON DILATATION CATHETER
K130804
Boston Scientific Corporation
Gastroenterology & Urology · 58d
Cleared May 26, 2005
U-BALLOON DILATION CATHETER
K050875
C.R. Bard, Inc.
Gastroenterology & Urology · 50d
Cleared Jan 31, 2000
BARD UROFORCE BALLOON DILATION CATHETER
K993840
C.R. Bard, Inc.
Gastroenterology & Urology · 80d
Cleared Apr 22, 1998
UROLOGICAL BALLOON DILATATION CATHETER
K980795
Boston Scientific Corp
Gastroenterology & Urology · 51d
Cleared Oct 09, 1996
BARD A-TRAC UROLOGICAL BALLOON DILATION CATHETER
K962921
C.R. Bard, Inc.
Gastroenterology & Urology · 75d
Cleared Sep 13, 1995
DILATATION CATHETER, BALLOON
K953004
Boston Scientific Corp
Gastroenterology & Urology · 77d
Cleared Sep 12, 1994
PASSPORT
K941853
Boston Scientific Corp
Gastroenterology & Urology · 151d
Cleared Feb 14, 1994
UROLOGICAL BALLOON DILATATION CATHETER
K935379
Boston Scientific Corp
Gastroenterology & Urology · 97d
Cleared Feb 01, 1994
MICROVASIVE UROLOGICAL BALLOON DILATION CATHETER
K933011
Boston Scientific Corp
Gastroenterology & Urology · 225d
Cleared Jul 01, 1992
UROLOGICAL BALLOON DILATATION CATHETER
K920946
Boston Scientific Corp
Gastroenterology & Urology · 121d
Cleared Dec 20, 1991
CATHETER, URETERAL DILATOR
K914617
Boston Scientific Corp
Gastroenterology & Urology · 64d
Cleared Nov 07, 1990
URETERAL BALLOON DILATATION CATHETER
K903813
Boston Scientific Corp
Gastroenterology & Urology · 79d

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 510(k) Review Time - EZN Product Code

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 →