KOD · Class II · 21 CFR 876.5130

FDA Product Code KOD: Catheter, Urological

Leading manufacturers include C.R. Bard, Inc., Abco Dealers, Inc. and Van-Tec, Inc..

238
Total
238
Cleared
90d
Avg days
1976
Since
Declining activity - 1 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 251d recently vs 89d historically

FDA 510(k) Cleared Catheter, Urological Devices (Product Code KOD)

238 devices
1–24 of 238
Cleared Feb 23, 2026
Rubber Utility Catheter
K251864
C.R. Bard, Inc.
Gastroenterology & Urology · 251d
Cleared Dec 16, 2022
Wellead Ureteral Catheter
K220036
Well Lead Medical Co., Ltd.
Gastroenterology & Urology · 345d
Cleared Oct 13, 2022
allFlex Ureteral Catheters, Krait Ureteral Catheters
K220730
Allwin Medical Devices, Inc.
Gastroenterology & Urology · 213d
Cleared Nov 19, 2021
Urinary Catheter 12 Fr, Urinary Catheter 16 Fr
K211032
Urogen Pharma, Ltd.
Gastroenterology & Urology · 226d
Cleared May 24, 2019
Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter
K181979
Teleflexmedical, Inc.
Gastroenterology & Urology · 303d
Cleared Oct 30, 2018
UroGen Ureteral Catheter
K180354
Urogen Pharma, Ltd.
Gastroenterology & Urology · 264d
Cleared Jun 28, 2018
Angled Tip Ureteral Catheter
K181144
Cook Incorporated
Gastroenterology & Urology · 58d
Cleared Apr 10, 2018
Imager II Urology Torque Catheter
K180530
Boston Scientific Corporation
Gastroenterology & Urology · 41d
Cleared Mar 07, 2018
Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter
K171810
Cook Incorporated
Gastroenterology & Urology · 261d
Cleared Feb 16, 2018
Renal Access Cobra Catheter, Kumpe Access Catheter
K171600
Cook Incorporated
Gastroenterology & Urology · 260d
Cleared Feb 01, 2018
Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter
K171662
Cook Incorporated
Gastroenterology & Urology · 241d
Cleared Nov 21, 2017
GentleCath Intermittent Urinary Catheter
K172924
Convatec Limited
Gastroenterology & Urology · 57d
Cleared Sep 20, 2016
GentleCath Glide Intermittent Catheter
K161344
Convatec Limited
Gastroenterology & Urology · 130d
Cleared May 20, 2016
United Urologics Closed System Catheter
K160877
Robling Medical, Inc.
Gastroenterology & Urology · 51d
Cleared Aug 01, 2014
GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER
K140953
Convatec, Ltd.
Gastroenterology & Urology · 109d
Cleared Mar 16, 2011
BACKSTOP CATHETER
K110491
Pluromed, Inc.
Gastroenterology & Urology · 22d
Cleared Jan 07, 2011
BACKSTOP CATHETER
K103349
Pluromed, Inc.
Gastroenterology & Urology · 52d
Cleared Nov 05, 2010
IMAGER II UROLOGY TORQUE CATHETER (C1 TIP)
K102527
Boston Scientific Corporation
Gastroenterology & Urology · 64d
Cleared Jul 07, 2004
DOVER RED RUBBER ROBINSON CATHETER
K041243
Tyco Healthcare
Gastroenterology & Urology · 57d
Cleared Feb 04, 2004
BARD TIGERTAIL URETERAL CATHETER
K033719
C.R. Bard, Inc.
Gastroenterology & Urology · 70d
Cleared Dec 23, 2003
INTERMITTENT URETHRAL CATHETERS
K033023
Rusch Intl.
Gastroenterology & Urology · 88d
Cleared Sep 13, 2002
URETERAL ACCESS SHEATH SET (UASS)
K022135
Boston Scientific Corp
Gastroenterology & Urology · 74d
Cleared Jan 14, 2002
INCARE ADVANCE
K013483
Hollister, Inc.
Gastroenterology & Urology · 87d
Cleared Jan 07, 2002
INCARE INTERMITTENT CATHETER
K013345
Hollister, Inc.
Gastroenterology & Urology · 90d

About Product Code KOD - Regulatory Context

510(k) Submission Activity

238 total 510(k) submissions under product code KOD since 1976, with 238 receiving FDA clearance (average review time: 90 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.

FDA 510(k) Review Time - KOD Product Code

Recent submissions under KOD have taken an average of 251 days to reach a decision - up from 89 days historically. Manufacturers should account for longer review timelines in current project planning.

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