Panels › Gastroenterology, Urology › Product code KOD · Class 2
Catheter, Urological
Regulation 876.5130
1510(k)s in 12 months (238 all time)
1recalls in 12 months (108 all time)
80recalls that name a 510(k)
Top companies in KOD
| Company | 510(k)s | Recalls |
|---|---|---|
| Nurse Assist, Inc | 0 | 34 |
| C.R. Bard, Inc. | 10 | 12 |
| COVIDIEN LLC | 0 | 17 |
| Teleflex Medical | 0 | 17 |
| Rochester Medical Corp. | 2 | 14 |
| Convatec Limited | 3 | 7 |
| Abco Dealers, Inc. | 9 | 0 |
| Van-Tec, Inc. | 8 | 0 |
| Boston Scientific Corp | 5 | 2 |
| The Kendal Co. | 7 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 23, 2026 | K251864 | Rubber Utility Catheter C.R. Bard, Inc. | KOD |
| Dec 16, 2022 | K220036 | Wellead Ureteral Catheter Well Lead Medical Co., Ltd., CN | KOD |
| Oct 13, 2022 | K220730 | allFlex Ureteral Catheters, Krait Ureteral Catheters Allwin Medical Devices, Inc. | KOD |
| Nov 19, 2021 | K211032 | Urinary Catheter 12 Fr, Urinary Catheter 16 Fr Urogen Pharma, Ltd., IL | KOD |
| May 24, 2019 | K181979 | Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter Teleflexmedical, Inc. | KOD |
| Oct 30, 2018 | K180354 | UroGen Ureteral Catheter Urogen Pharma, Ltd., IL | KOD |
| Jun 28, 2018 | K181144 | Angled Tip Ureteral Catheter Cook Incorporated | KOD |
| Apr 10, 2018 | K180530 | Imager II Urology Torque Catheter Boston Scientific Corporation | KOD |
| Mar 7, 2018 | K171810 | Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter Cook Incorporated | KOD |
| Feb 16, 2018 | K171600 | Renal Access Cobra Catheter, Kumpe Access Catheter Cook Incorporated | KOD |
| Feb 1, 2018 | K171662 | Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Cook Incorporated | KOD |
| Nov 21, 2017 | K172924 | GentleCath Intermittent Urinary Catheter Convatec Limited, GB | KOD |
| Sep 20, 2016 | K161344 | GentleCath Glide Intermittent Catheter Convatec Limited, GB | KOD |
| May 20, 2016 | K160877 | United Urologics Closed System Catheter Robling Medical, Inc. | KOD |
| Aug 1, 2014 | K140953 | GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER Convatec, Ltd., GB | KOD |
| Mar 16, 2011 | K110491 | BACKSTOP CATHETER Pluromed, Inc. | KOD |
| Jan 7, 2011 | K103349 | BACKSTOP CATHETER Pluromed, Inc. | KOD |
| Nov 5, 2010 | K102527 | IMAGER II UROLOGY TORQUE CATHETER (C1 TIP); IMAGER II UROLOGY TORQUE CATHETER (C2 TIP; IMAGER II UROLOGY TORQUE CATHETER Boston Scientific Corporation | KOD |
| May 15, 2009 | K090270 | BACKSTOP CATHETER, MODEL 60-0000-3100 Pluromed, Inc. | KOD |
| Jul 17, 2008 | K080878 | MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT) Medical Technologies of Georgia, Inc. | KOD |
| Jun 11, 2008 | K080881 | CURE CATHETER CLOSED SYSTEM Cure Medical, LLC | KOD |
| Jul 20, 2004 | K040897 | DOVER ROB-NEL CATHETER Tyco Healthcare | KOD |
| Jul 7, 2004 | K041243 | DOVER RED RUBBER ROBINSON CATHETER Tyco Healthcare | KOD |
| Feb 4, 2004 | K033719 | BARD TIGERTAIL URETERAL CATHETER C.R. Bard, Inc. | KOD |
| Jan 9, 2004 | K032710 | CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT Apogee Medical, Inc. | KOD |
| Dec 23, 2003 | K033023 | INTERMITTENT URETHRAL CATHETERS Rusch Intl. | KOD |
| Sep 13, 2002 | K022135 | URETERAL ACCESS SHEATH SET (UASS) Boston Scientific Corp | KOD |
| Jan 14, 2002 | K013483 | INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT Hollister, Inc. | KOD |
| Jan 7, 2002 | K013345 | INCARE INTERMITTENT CATHETER Hollister, Inc. | KOD |
| Jul 13, 2001 | K011965 | IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1 Boston Scientific Corp | KOD |
| Mar 7, 2001 | K010339 | ENDOCARE PERCUTANEOUS ACCESS SET Endocare, Inc. | KOD |
| Oct 13, 2000 | K002396 | ENDOCARE PERCUTANEOUS ACCESS SET Endocare, Inc. | KOD |
| Jul 13, 2000 | K001583 | ISLAND BIOSURGICAL BNS KIT #3 Island Biosurgical, LLC | KOD |
| May 19, 2000 | K000723 | HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC) Rochester Medical Corp. | KOD |
| Feb 18, 2000 | K000070 | FLOCATH Rusch Intl. | KOD |
| Mar 4, 1997 | K965229 | IMAGER TORQUE CATHETER Boston Scientific Corp | KOD |
| Sep 27, 1995 | K951260 | URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT Biosearch Medical Products, Inc. | KOD |
| Mar 9, 1995 | K945061 | NOPROFILE OLBERT CATHETER SYSTEM Meadox Surgimed, Inc. | KOD |
| Apr 14, 1994 | K922527 | BARD URODYNAMIC CATHETERIZATION PROCEDURE TRAY C.R. Bard, Inc. | KOD |
| Mar 28, 1994 | K933109 | 4SURE URO-LINK UROLOGICAL PROCEDURE TRAYS Boston Pacific Medical, Inc. | KOD |
| Feb 15, 1994 | K915459 | FLOWMATE HAND PUMP Psi Medical Products, Inc. | KOD |
| Dec 22, 1993 | K931195 | PERCUTANEOUS DRAINAGE LOOP CATHETER SET Cook Urological, Inc. | KOD |
| Nov 15, 1993 | K933400 | KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMPERATURE SENSOR Kendall Healthcare Products Co. Div.Of Tyco Health | KOD |
| Jul 9, 1993 | K930608 | ONIK-COHEN ACCESS SET Cook Urological, Inc. | KOD |
| Jun 22, 1993 | K923906 | FOLEY INSERTION TRAY Kit Pak, Inc. | KOD |
| Jun 17, 1993 | K922051 | KIT PAK'S FLUSHING KIT Kit Pak, Inc. | KOD |
| Mar 25, 1993 | K922431 | BARD LATEX URINARY CATHETERS C.R. Bard, Inc. | KOD |
| Oct 2, 1992 | K923607 | RADIFOCUS GUIDE WIRE M Terumo Medical Corp. | KOD |
| Sep 23, 1992 | K921054 | KENDALL MOD. PEDIATRIC ULTRAMER POLYURETHANE CATH. Kendall Healthcare Products Co. Div.Of Tyco Health | KOD |
| Sep 4, 1992 | K921415 | IRRIGATION TUBING SET Psi Medical Products, Inc. | KOD |
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