Product code KOD
- Device name
- Catheter, Urological
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5130
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251864 | Rubber Utility Catheter | C.R. Bard, Inc. | 2026-02-23 |
| K220036 | Wellead Ureteral Catheter | Well Lead Medical Co., Ltd. | 2022-12-16 |
| K220730 | allFlex Ureteral Catheters, Krait Ureteral Catheters | Allwin Medical Devices, Inc. | 2022-10-13 |
| K211032 | Urinary Catheter 12 Fr, Urinary Catheter 16 Fr | Urogen Pharma, Ltd. | 2021-11-19 |
| K181979 | Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter | Teleflexmedical, Inc. | 2019-05-24 |
| K180354 | UroGen Ureteral Catheter | Urogen Pharma, Ltd. | 2018-10-30 |
| K181144 | Angled Tip Ureteral Catheter | Cook Incorporated | 2018-06-28 |
| K180530 | Imager II Urology Torque Catheter | Boston Scientific Corporation | 2018-04-10 |
| K171810 | Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter | Cook Incorporated | 2018-03-07 |
| K171600 | Renal Access Cobra Catheter, Kumpe Access Catheter | Cook Incorporated | 2018-02-16 |
| K171662 | 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 Cathet... | Cook Incorporated | 2018-02-01 |
| K172924 | GentleCath Intermittent Urinary Catheter | Convatec Limited | 2017-11-21 |
| K161344 | GentleCath Glide Intermittent Catheter | Convatec Limited | 2016-09-20 |
| K160877 | United Urologics Closed System Catheter | Robling Medical, Inc. | 2016-05-20 |
| K140953 | GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER | Convatec, Ltd. | 2014-08-01 |
| K110491 | BACKSTOP CATHETER | Pluromed, Inc. | 2011-03-16 |
| K103349 | BACKSTOP CATHETER | Pluromed, Inc. | 2011-01-07 |
| K102527 | IMAGER II UROLOGY TORQUE CATHETER (C1 TIP); IMAGER II UROLOGY TORQUE CATHETER (C2 TIP; IMAGER II UROLOGY TORQUE CATHETER | Boston Scientific Corporation | 2010-11-05 |
| K090270 | BACKSTOP CATHETER, MODEL 60-0000-3100 | Pluromed, Inc. | 2009-05-15 |
| K080878 | MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT) | Medical Technologies of Georgia, Inc. | 2008-07-17 |
| K080881 | CURE CATHETER CLOSED SYSTEM | Cure Medical, LLC | 2008-06-11 |
| K040897 | DOVER ROB-NEL CATHETER | Tyco Healthcare | 2004-07-20 |
| K041243 | DOVER RED RUBBER ROBINSON CATHETER | Tyco Healthcare | 2004-07-07 |
| K033719 | BARD TIGERTAIL URETERAL CATHETER | C.R. Bard, Inc. | 2004-02-04 |
| K032710 | CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT | Apogee Medical, Inc. | 2004-01-09 |
| K033023 | INTERMITTENT URETHRAL CATHETERS | Rusch Intl. | 2003-12-23 |
| K022135 | URETERAL ACCESS SHEATH SET (UASS) | Boston Scientific Corp | 2002-09-13 |
| K013483 | INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT | Hollister, Inc. | 2002-01-14 |
| K013345 | INCARE INTERMITTENT CATHETER | Hollister, Inc. | 2002-01-07 |
| K011965 | IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1 | Boston Scientific Corp | 2001-07-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08714729751687 | Ureteral Catheter | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729751991 | Imager II | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729751984 | Imager II | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729751977 | Imager II | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729751960 | Imager II | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729751953 | Imager II | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729751946 | Imager II | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729751939 | Imager II | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729751922 | Imager II | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729751915 | Ureteral Catheter | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729751892 | Ureteral Catheter | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729751885 | Ureteral Catheter | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729751861 | Ureteral Catheter | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729751854 | Ureteral Catheter | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729751694 | Ureteral Catheter | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729012689 | NA | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729751670 | Ureteral Catheter | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729751663 | Ureteral Catheter | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729751601 | Ureteral Catheter | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729751595 | Ureteral Catheter | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729751588 | Ureteral Catheter | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729751571 | Ureteral Catheter | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729751564 | Ureteral Catheter | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729751540 | Navigator | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729751533 | Navigator | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729751526 | Navigator | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729751519 | Navigator | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729751502 | Navigator | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729735519 | Percufix™ Catheter Cuff | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729470342 | Navigator | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |