FDA 510(k) Applications for Medical Device Product Code "KOD"
(Catheter, Urological)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K220730 | Allwin Medical Devices, Inc | allFlex Ureteral Catheters, Krait Ureteral Catheters | 10/13/2022 |
| K032710 | APOGEE MEDICAL, INC. | CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT | 01/09/2004 |
| K011965 | BOSTON SCIENTIFIC CORP. | IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1 | 07/13/2001 |
| K965229 | BOSTON SCIENTIFIC CORP. | IMAGER TORQUE CATHETER | 03/04/1997 |
| K022135 | BOSTON SCIENTIFIC CORP. | URETERAL ACCESS SHEATH SET (UASS) | 09/13/2002 |
| K180530 | Boston Scientific Corporation | Imager II Urology Torque Catheter | 04/10/2018 |
| K102527 | Boston Scientific Corporation | IMAGER II UROLOGY TORQUE CATHETER (C1 TIP); IMAGER II UROLOGY TORQUE CATHETER (C2 TIP; IMAGER II UROLOGY TORQUE CATHETER | 11/05/2010 |
| K033719 | C.R. BARD, INC. | BARD TIGERTAIL URETERAL CATHETER | 02/04/2004 |
| K161344 | CONVATEC LIMITED | GentleCath Glide Intermittent Catheter | 09/20/2016 |
| K172924 | ConvaTec Limited | GentleCath Intermittent Urinary Catheter | 11/21/2017 |
| K140953 | CONVATEC LTD. | GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER | 08/01/2014 |
| K181144 | Cook Incorporated | Angled Tip Ureteral Catheter | 06/28/2018 |
| K171810 | Cook Incorporated | Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter | 03/07/2018 |
| K171662 | Cook Incorporated | 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 Ure | 02/01/2018 |
| K171600 | Cook Incorporated | Renal Access Cobra Catheter, Kumpe Access Catheter | 02/16/2018 |
| K080881 | CURE MEDICAL LLC. | CURE CATHETER CLOSED SYSTEM | 06/11/2008 |
| K002396 | ENDOCARE, INC. | ENDOCARE PERCUTANEOUS ACCESS SET | 10/13/2000 |
| K010339 | ENDOCARE, INC. | ENDOCARE PERCUTANEOUS ACCESS SET | 03/07/2001 |
| K013483 | HOLLISTER, INC. | INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT | 01/14/2002 |
| K013345 | HOLLISTER, INC. | INCARE INTERMITTENT CATHETER | 01/07/2002 |
| K001583 | ISLAND BIOSURGICAL, LLC. | ISLAND BIOSURGICAL BNS KIT #3 | 07/13/2000 |
| K080878 | MEDICAL TECHNOLOGIES OF GEORGIA, INC. | MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT) | 07/17/2008 |
| K183335 | Medline Industries, Inc. | Medline Poly-Cath Red Polymer Urethral Catheter | 06/12/2019 |
| K103349 | PLUROMED, INC. | BACKSTOP CATHETER | 01/07/2011 |
| K110491 | PLUROMED, INC. | BACKSTOP CATHETER | 03/16/2011 |
| K090270 | PLUROMED, INC. | BACKSTOP CATHETER, MODEL 60-0000-3100 | 05/15/2009 |
| K160877 | ROBLING MEDICAL, INC. | United Urologics Closed System Catheter | 05/20/2016 |
| K000723 | ROCHESTER MEDICAL CORP. | HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC) | 05/19/2000 |
| K000070 | RUSCH INTL. | FLOCATH | 02/18/2000 |
| K033023 | RUSCH INTL. | INTERMITTENT URETHRAL CATHETERS | 12/23/2003 |
| K181979 | Teleflex Medical, Inc. | Rusch FloCath Quick 18 Fr. CoudΘ Hydrophilic Intermittent Catheter | 05/24/2019 |
| K041243 | TYCO HEALTHCARE | DOVER RED RUBBER ROBINSON CATHETER | 07/07/2004 |
| K040897 | TYCO HEALTHCARE | DOVER ROB-NEL CATHETER | 07/20/2004 |
| K211032 | UroGen Pharma Ltd | Urinary Catheter 12 Fr, Urinary Catheter 16 Fr | 11/19/2021 |
| K180354 | UroGen Pharma Ltd. | UroGen Ureteral Catheter | 10/30/2018 |
| K220036 | Well Lead Medical Co., Ltd. | Wellead Ureteral Catheter | 12/16/2022 |
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