FDA 510(k) Applications for Medical Device Product Code "EZL"
(Catheter, Retention Type, Balloon)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K022287 | 3T MEDICAL SYSTEMS, LLC. | 3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS | 09/23/2002 |
| K051059 | AMSINO INTERNATIONAL, INC. | AMSURE 100% SILICONE FOLEY CATHETER | 06/28/2005 |
| K101824 | AMSINO INTERNATIONAL, INC. | AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER | 09/13/2010 |
| K030120 | AMSINO INTERNATIONAL, INC. | AMSURE FOLEY CATHETER | 10/29/2003 |
| K091699 | AMSINO INTERNATIONAL, INC. | AMSURE HYDROPHILIC LATEX FOLEY CATHETER | 08/10/2009 |
| K181814 | Amsino International, Inc. | AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water | 09/04/2018 |
| K201776 | Apollon co., Ltd. | Foley Balloon Catheter for Urology | 12/30/2020 |
| K010006 | APPLIED MEDICAL RESOURCES CORP. | DRAINAGE CATHETER OR FOLEY CATHETER | 07/25/2001 |
| K984084 | BARD MEDICAL DIV. | BARDEX LUBRI-SIL FOLEY CATHETER | 02/01/1999 |
| K042110 | BEAMPOINT AB | BEAMCATH | 02/25/2005 |
| K182463 | Biosensors International Pte Ltd | Silicone Foley Catheter | 11/06/2019 |
| K180781 | C. R. Bard, Inc. | Bard Vertus Foley Catheter | 09/19/2018 |
| K002868 | C.R. BARD, INC. | BARD ALL-SILICONE 3-WAY FOLEY CATHETER; BARD LUBRI-SIL 3-WAY FOLEY CATHETER; BARD LUBRI-SIL I.C. 3-WAY FOLEY CATHETER | 12/08/2000 |
| K150699 | C.R. Bard, Inc. | Bard LubriGuard Foley Catheter | 07/28/2015 |
| K070582 | C.R. BARD, INC. | BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS | 12/07/2007 |
| K002612 | C.R. BARD, INC. | BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL 3CC BALLOON: 17008,170010,5CC BALLOON | 09/03/2002 |
| K003289 | C.R. BARD, INC. | BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED); BARDEX LUBRI-SIL TEMPERATURE-SENSING FOLEY CATHETER (LU | 01/05/2001 |
| K070508 | C.R. BARD, INC. | BARDEX LUBRI-SIL ALL-SILICONE LUBRICIOUS COATED FOLEY CATHETER 6 FR | 03/09/2007 |
| K070558 | C.R. BARD, INC. | BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SILICONE FOLEY CATHETERS | 12/07/2007 |
| K040504 | C.R. BARD, INC. | BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERS | 05/14/2004 |
| K172807 | Changzhou Rongxin Medicine Minimal Invasion Technology | Silicone Foley Catheter for single use | 06/04/2018 |
| K964757 | CONTIMED, INC. | CONTIDRAIN CATHETER | 06/25/1997 |
| K173657 | Cook Incorporated | Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter | 08/23/2018 |
| K091767 | COOK UROLOGICAL, INC. | 3 WAY SILICONE FOLEY BALLOON CATHETER | 10/09/2009 |
| K150550 | COVALON TECHNOLOGIES, INC. | SilverCoat Silicone Foley Catheter | 11/24/2015 |
| K063442 | DEGANIA SILICONE, LTD. | ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR | 03/26/2007 |
| K103371 | DEGANIA SILICONE, LTD. | COUDE/ OR TIEMANN | 03/11/2011 |
| K131020 | DEGANIA SILICONE, LTD. | TEMPERATURE SENSOR CATHETER | 05/09/2013 |
| K181346 | Emmy Medical, LLC. | CystoSure Plus Catheter | 08/06/2018 |
| K053429 | ENTRACARE, LLC | ADVANCED UROLOGICAL CATHETER | 02/08/2006 |
| K231101 | Flume Catheter Company, Ltd. | Flume Catheter | 06/29/2023 |
| K980919 | FORTUNE MEDICAL INSTRUMENT CORP. | ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER | 03/31/1998 |
| K021142 | FORTUNE MEDICAL INSTRUMENT CORP. | ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865 | 10/01/2002 |
| K130908 | GUANGDONG BAIHE MEDICAL TECHNOLOGY CO., LTD | DISPOSABLE SILICONE FOLEY CATHETER | 10/03/2013 |
| K202698 | Hangzhou Primecare Medical Co., Ltd. | Prefilled Syringe | 12/15/2020 |
| K200556 | HR Pharmaceuticals, Inc. | AquaFlate Pre-Filled Sterile Water Syringe 10mL | 03/31/2020 |
| K990509 | IMPLEMED, INC. | OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818 | 05/18/1999 |
| K173340 | Jiangxi Yikang Medical Instrument Group Co., LTD. | Yikang Latex Foley Catheter | 07/13/2018 |
| K971801 | LOUISVILLE LABORATORIES, INC. | LAPAROTOMY BLADDER NECK SUSPENSION KIT | 07/22/1997 |
| K971796 | LOUISVILLE LABORATORIES, INC. | LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS | 08/12/1997 |
| K961697 | MEDICAL DEVICE INTL., INC. | OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE | 08/30/1996 |
| K071423 | MEDLINE INDUSTRIES, INC. | MEDLINE LATEX FOLEY CATHETER | 07/18/2007 |
| K142635 | MEDLINE INDUSTRIES, INC. | Medline Silicone Foley Catheter | 01/09/2015 |
| K052168 | MEDLINE INDUSTRIES, INC. | MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE INDUSTRIES, INC. | 02/16/2006 |
| K982626 | MEDWORKS CORP. | URETHROPEXY SUTURE PLACEMENT KIT MODEL NUMBERS UM-300, MW-100, MINI-LAPAROTOMY MMK KIT MODEL UM-250, LAPAROSCOPIC BURCH0 | 08/20/1998 |
| K003784 | MENTOR CORP. | MENTOR SELF-CATH PLUS | 03/05/2001 |
| K944676 | MRI MANUFACTURING AND RESEARCH, INC. | MRI'S ALL SILICONE FOLEY CATHETER | 04/05/1996 |
| K982970 | MRI MANUFACTURING AND RESEARCH, INC. | MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER | 10/28/1998 |
| K172422 | Nellie Medical, LLC | Kohli Urinary Drainage Catheter | 02/09/2018 |
| K041983 | OPTICON MEDICAL | OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016 | 11/17/2004 |
| K970716 | OPTICON MEDICAL, INC. | OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE | 05/16/1997 |
| K033830 | OPTICON MEDICAL, INC. | OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000 | 01/09/2004 |
| K023090 | OPTICON MEDICAL, INC. | OPTION-VF URINARY CATHETER, FV14218 | 03/19/2003 |
| K192034 | Pathway, LLC | HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc | 04/21/2020 |
| K181616 | Pathway, LLC | PSM 3-Way Silicone Foley Catheter | 09/21/2018 |
| K110214 | PERCUVISION | DIRECTVISION CATHETER, UNCOATED | 05/27/2011 |
| K090262 | PERCUVISION LLC | PERCUCATH URINARY CATHETER | 05/28/2009 |
| K173533 | Poiesis Medical, LLC | Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter | 03/29/2018 |
| K013172 | PORGES S.A. | PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL | 12/20/2001 |
| K013174 | PORGES S.A. | PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL, | 01/04/2002 |
| K153655 | POTRERO MEDICAL, INC. | Accuryn Monitoring System | 04/15/2016 |
| K221020 | Potrero Medical, Inc. | Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F | 01/13/2023 |
| K030813 | PRIMARY CARE SOLUTIONS, INC. | PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND | 05/30/2003 |
| K944673 | REGULATORY & MARKETING SERVICES, INC. | MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE | 04/10/1996 |
| K981612 | ROCHESTER MEDICAL CORP. | ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETER | 07/08/1998 |
| K971643 | RUSCH INTL. | RUSCH BRILLANT BALLOON CATHETER | 10/07/1997 |
| K993063 | RUSCH INTL. | RUSCH BRILLANT SILICONE FOLEY | 12/09/1999 |
| K972184 | RUSCH INTL. | RUSCH BRILLANT SILICONE FOLEY CATHETER | 01/08/1998 |
| K964575 | RUSCH INTL. | SYMPACATH HYDROGEL COATED FOLEY | 02/04/1997 |
| K980870 | RUSCH, INC. | RUSCH SILICONE FOLEY CATHETER | 06/09/1998 |
| K974419 | RUSCH, INC. | RUSCH SIMPLASTIC COUNCILL TIP CATHETER | 01/27/1998 |
| K182635 | Safe Medical Design | Signal Catheter | 01/10/2019 |
| K140099 | SEEDINGS LIFE SCIENCE VENTURES, LLC | LIGHTHOUSE URINARY CATHETER | 03/04/2014 |
| K131655 | SEEDINGS LIFE SCIENCE VENTURES, LLC | LIGHTHOUSE(TM) URINARY CATHETER | 11/04/2013 |
| K013276 | SEWOON MEDICAL CO., LTD. | ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE) | 02/15/2002 |
| K221625 | Silq Technologies Corporation | 2-Way 100% Silicone ClearTract Catheter | 07/01/2022 |
| K222118 | SILQ Technologies, Corp. | 2-Way 100% Silicone Cleartract Catheter | 12/01/2022 |
| K062112 | SUNMED, INC. | SUNMED FOLEY CATHETERS | 06/04/2007 |
| K161770 | Teleflex Medical, Inc. | Rusch Silicone Foley Catheter | 05/05/2017 |
| K162989 | TELEFLEX MEDICAL, INC. | Rusch Simplastic Foley Catheters | 02/24/2017 |
| K212077 | Teleflex Medical, Inc. | Teleflex Rusch SoftSimplastic Foley Catheters | 07/27/2023 |
| K212151 | The Flume Catheter Company, Ltd. | FLUME catheter | 11/03/2021 |
| K990500 | THE KENDAL CO. | KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C | 09/28/1999 |
| K024010 | THE KENDALL COMPANY DIV. OF TYCO HEALTHCARE GROUP | DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER | 06/11/2003 |
| K071049 | TYCO HEALTHCARE | DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR | 10/16/2007 |
| K042709 | TYCO HEALTHCARE | DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER | 01/18/2005 |
| K082919 | UC-CARE MEDICAL SYSTEMS LTD | UC-CARE POSITIONING SYSTEM | 10/27/2008 |
| K973076 | UNOMEDICAL SDN BHD | EUROMEDICAL HAEMATURIA FOLEY CATHETER | 09/16/1998 |
| K190060 | Urethrotech | Urethrotech UCD | 10/04/2019 |
| K031748 | VITALCARE GROUP, INC. | VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES | 08/27/2003 |
| K021939 | VITALCARE, INC. | VITALCARE FOLEY CATHETER | 04/22/2003 |
| K140667 | WELL LEAD MEDICAL CO. LTD | WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER | 12/15/2014 |
| K091516 | WELL LEAD MEDICAL CO. LTD | WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR | 10/16/2009 |
| K202134 | Well Lead Medical Co., LTD. | Well Lead All Silicone Foley Catheter with Temperature Sensor | 04/08/2021 |
| K082815 | WELL LEAD MEDICAL INSTRUMENTS | WELL LEAD SILICONE AND LATEX FOLEY CATHETERS | 10/08/2008 |
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