FDA Product Code KOD: Catheter, Urological
Leading manufacturers include C.R. Bard, Inc., Medline Industries, Inc. and Cook Incorporated.
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
Cleared
Feb 23, 2026
Rubber Utility Catheter
C.R. Bard, Inc.
Gastroenterology & Urology
251d
Cleared
Dec 16, 2022
Wellead Ureteral Catheter
Well Lead Medical Co., Ltd.
Gastroenterology & Urology
345d
Cleared
Oct 13, 2022
allFlex Ureteral Catheters, Krait Ureteral Catheters
Allwin Medical Devices, Inc.
Gastroenterology & Urology
213d
Cleared
Nov 19, 2021
Urinary Catheter 12 Fr, Urinary Catheter 16 Fr
Urogen Pharma, Ltd.
Gastroenterology & Urology
226d
Cleared
May 24, 2019
Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter
Teleflexmedical, Inc.
Gastroenterology & Urology
303d
Cleared
Oct 30, 2018
UroGen Ureteral Catheter
Urogen Pharma, Ltd.
Gastroenterology & Urology
264d
Cleared
Jun 28, 2018
Angled Tip Ureteral Catheter
Cook Incorporated
Gastroenterology & Urology
58d
Cleared
Apr 10, 2018
Imager II Urology Torque Catheter
Boston Scientific Corporation
Gastroenterology & Urology
41d
Cleared
Mar 07, 2018
Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter
Cook Incorporated
Gastroenterology & Urology
261d
Cleared
Feb 16, 2018
Renal Access Cobra Catheter, Kumpe Access Catheter
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
Cook Incorporated
Gastroenterology & Urology
241d
Cleared
Nov 05, 2010
IMAGER II UROLOGY TORQUE CATHETER (C1 TIP)
Boston Scientific Corporation
Gastroenterology & Urology
64d
Cleared
Feb 04, 2004
BARD TIGERTAIL URETERAL CATHETER
C.R. Bard, Inc.
Gastroenterology & Urology
70d
Cleared
Sep 13, 2002
URETERAL ACCESS SHEATH SET (UASS)
Boston Scientific Corp
Gastroenterology & Urology
74d
Cleared
Jul 13, 2001
IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1
Boston Scientific Corp
Gastroenterology & Urology
18d
Cleared
Mar 04, 1997
IMAGER TORQUE CATHETER
Boston Scientific Corp
Gastroenterology & Urology
63d
Cleared
Apr 14, 1994
BARD URODYNAMIC CATHETERIZATION PROCEDURE TRAY
C.R. Bard, Inc.
Gastroenterology & Urology
686d
Cleared
Mar 25, 1993
BARD LATEX URINARY CATHETERS
C.R. Bard, Inc.
Gastroenterology & Urology
307d
Cleared
Nov 21, 1990
PHARMASEAL DISPOSABLE ABDOMINAL TROCAR
Baxter Healthcare Corp
Gastroenterology & Urology
35d
Cleared
Apr 17, 1990
BARD CONFORMACATH FOLEY CATHETER
C.R. Bard, Inc.
Gastroenterology & Urology
90d
Cleared
Aug 02, 1988
CATHETER STRAP
Baxter Healthcare Corp
Gastroenterology & Urology
98d
Cleared
May 09, 1984
UROLOGICAL KIT W/STERILE, WATER-FILL
Medline Industries, Inc.
Gastroenterology & Urology
29d
Cleared
Feb 04, 1984
TEMPERATURE SENSING FOLEY CATHETER
C.R. Bard, Inc.
Gastroenterology & Urology
47d
Cleared
Jul 21, 1982
DYNACOR URETHRAL CATHETER TRAY
Medline Industries, Inc.
Gastroenterology & Urology
20d
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 →