FDA Product Code
FDA Product Code EZL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5130
510(k) Clearances — 130 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260756 | TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221) | Sentinel Medical Technologies, | 2026-09-04 | Traditional | PDF ↗ |
| K262056 | Rusch Latex Gold Foley Catheter | Teleflex Medical Sdn. Bhd. | 2026-08-05 | Traditional | PDF ↗ |
| K252537 | Rusch SoftSimplastic Foley Catheters | Teleflex Medical Sdn. Bhd. | 2026-01-20 | Traditional | PDF ↗ |
| K243011 | Silicone Urethral Catheter (Silicone Urethral Catheter) | Guangdong Ecan Medical Co., Ltd. | 2025-06-16 | Traditional | PDF ↗ |
| K241424 | InnoCare Specialty Foley Catheter | Innocare Urologics, LLC | 2024-09-18 | Traditional | PDF ↗ |
| K232469 | Rüsch Latex Gold Foley Catheter | Teleflexmedical, Inc. | 2024-08-01 | Traditional | PDF ↗ |
| K240057 | TraumaGuard Intra-abdominal Pressure Sensing System | Sentinel Medical Technologies, LLC | 2024-04-17 | Traditional | PDF ↗ |
| K233411 | Folysil Silicone Catheter | Coloplast Corp. | 2024-04-15 | Traditional | PDF ↗ |
| K233013 | 2-Way 100% Silicone Cleartract Catheter | Silq Technologies Corporation | 2024-01-23 | Traditional | PDF ↗ |
| K212077 | Teleflex Rusch SoftSimplastic Foley Catheters | Teleflexmedical, Inc. | 2023-07-27 | Traditional | PDF ↗ |
| K231101 | Flume Catheter | Flume Catheter Company, Ltd. | 2023-06-29 | Special | PDF ↗ |
| K221020 | Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F | Potrero Medical, Inc. | 2023-01-13 | Traditional | PDF ↗ |
| K222118 | 2-Way 100% Silicone Cleartract Catheter | Silq Technologies, Corp. | 2022-12-01 | Traditional | PDF ↗ |
| K221625 | 2-Way 100% Silicone ClearTract Catheter | Silq Technologies Corporation | 2022-07-01 | Special | PDF ↗ |
| K212151 | FLUME catheter | The Flume Catheter Company, Ltd. | 2021-11-03 | Traditional | PDF ↗ |
| K202134 | Well Lead All Silicone Foley Catheter with Temperature Sensor | Well Lead Medical Co., Ltd. | 2021-04-08 | Special | PDF ↗ |
| K201776 | Foley Balloon Catheter for Urology | Apollon Co., Ltd. | 2020-12-30 | Traditional | PDF ↗ |
| K202698 | Prefilled Syringe | Hangzhou Primecare Medical Co., Ltd. | 2020-12-15 | Traditional | PDF ↗ |
| K192034 | 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 | Pathway, LLC | 2020-04-21 | Traditional | PDF ↗ |
| K200556 | AquaFlate Pre-Filled Sterile Water Syringe 10mL | H R Pharmaceuticals, Inc. | 2020-03-31 | Traditional | PDF ↗ |
| K182463 | Silicone Foley Catheter | Biosensors International Pte, Ltd. | 2019-11-06 | Traditional | PDF ↗ |
| K190060 | Urethrotech UCD | Urethrotech | 2019-10-04 | Traditional | PDF ↗ |
| K182635 | Signal Catheter | Safe Medical Design | 2019-01-10 | Traditional | PDF ↗ |
| K181616 | PSM 3-Way Silicone Foley Catheter | Pathway, LLC | 2018-09-21 | Traditional | PDF ↗ |
| K180781 | Bard Vertus Foley Catheter | C.R. Bard, Inc. | 2018-09-19 | Traditional | PDF ↗ |
| K181814 | AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water | Amsino International, Inc. | 2018-09-04 | Traditional | PDF ↗ |
| K173657 | Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter | Cook Incorporated | 2018-08-23 | Traditional | PDF ↗ |
| K181346 | CystoSure Plus Catheter | Emmy Medical, LLC | 2018-08-06 | Traditional | PDF ↗ |
| K173340 | Yikang Latex Foley Catheter | Jiangxi Yikang Medical Instrument Group Co., Ltd. | 2018-07-13 | Traditional | PDF ↗ |
| K172807 | Silicone Foley Catheter for single use | Changzhou Rongxin Medicine Minimal Invasion Technology | 2018-06-04 | Traditional | PDF ↗ |
| K173533 | Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter | Poiesis Medical, LLC | 2018-03-29 | Traditional | PDF ↗ |
| K172422 | Kohli Urinary Drainage Catheter | Nellie Medical, LLC | 2018-02-09 | Traditional | PDF ↗ |
| K161770 | Rusch Silicone Foley Catheter | Teleflexmedical, Inc. | 2017-05-05 | Traditional | PDF ↗ |
| K162989 | Rusch Simplastic Foley Catheters | Teleflexmedical, Inc. | 2017-02-24 | Traditional | PDF ↗ |
| K153655 | Accuryn Monitoring System | Potrero Medical, Inc. | 2016-04-15 | Traditional | PDF ↗ |
| K150550 | SilverCoat Silicone Foley Catheter | Covalontechnologies, Inc. | 2015-11-24 | Traditional | PDF ↗ |
| K150699 | Bard LubriGuard Foley Catheter | C.R. Bard, Inc. | 2015-07-28 | Traditional | PDF ↗ |
| K142635 | Medline Silicone Foley Catheter | Medline Industries, Inc. | 2015-01-09 | Traditional | PDF ↗ |
| K140667 | WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER | Well Lead Medical Co., Ltd. | 2014-12-15 | Traditional | PDF ↗ |
| K140099 | LIGHTHOUSE URINARY CATHETER | Seedings Life Science Ventures, LLC | 2014-03-04 | Traditional | PDF ↗ |
| K131655 | LIGHTHOUSE(TM) URINARY CATHETER | Seedings Life Science Ventures, LLC | 2013-11-04 | Traditional | PDF ↗ |
| K130908 | DISPOSABLE SILICONE FOLEY CATHETER | Guangdong Baihe Medical Technology Co., Ltd. | 2013-10-03 | Traditional | PDF ↗ |
| K131020 | TEMPERATURE SENSOR CATHETER | Degania Silicone , Ltd. | 2013-05-09 | Special | PDF ↗ |
| K110214 | DIRECTVISION CATHETER, UNCOATED | Percuvision | 2011-05-27 | Special | PDF ↗ |
| K103371 | COUDE/ OR TIEMANN | Degania Silicone , Ltd. | 2011-03-11 | Traditional | PDF ↗ |
| K101824 | AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER | Amsino International, Inc. | 2010-09-13 | Traditional | PDF ↗ |
| K091516 | WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR | Well Lead Medical Co., Ltd. | 2009-10-16 | Traditional | PDF ↗ |
| K091767 | 3 WAY SILICONE FOLEY BALLOON CATHETER | Cook Urological, Inc. | 2009-10-09 | Traditional | PDF ↗ |
| K091699 | AMSURE HYDROPHILIC LATEX FOLEY CATHETER | Amsino International, Inc. | 2009-08-10 | Special | PDF ↗ |
| K090262 | PERCUCATH URINARY CATHETER | Percuvision, LLC | 2009-05-28 | Traditional | PDF ↗ |
| K082919 | UC-CARE POSITIONING SYSTEM | Uc-Care Medical Systems, Ltd. | 2008-10-27 | Traditional | PDF ↗ |
| K082815 | WELL LEAD SILICONE AND LATEX FOLEY CATHETERS | Well Lead Medical Instruments | 2008-10-08 | Traditional | PDF ↗ |
| K070558 | BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SILICONE FOLEY CATHETERS | C.R. Bard, Inc. | 2007-12-07 | Traditional | PDF ↗ |
| K070582 | BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS | C.R. Bard, Inc. | 2007-12-07 | Traditional | PDF ↗ |
| K071049 | DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR | Tyco Healthcare | 2007-10-16 | Traditional | PDF ↗ |
| K071423 | MEDLINE LATEX FOLEY CATHETER | Medline Industries, Inc. | 2007-07-18 | Abbreviated | PDF ↗ |
| K062112 | SUNMED FOLEY CATHETERS | Sunmed, Inc. | 2007-06-04 | Traditional | PDF ↗ |
| K063442 | ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR | Degania Silicone , Ltd. | 2007-03-26 | Traditional | PDF ↗ |
| K070508 | BARDEX LUBRI-SIL ALL-SILICONE LUBRICIOUS COATED FOLEY CATHETER 6 FR | C.R. Bard, Inc. | 2007-03-09 | Traditional | PDF ↗ |
| K052168 | MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE INDUSTRIES, INC. | Medline Industries, Inc. | 2006-02-16 | Traditional | PDF ↗ |
| K053429 | ADVANCED UROLOGICAL CATHETER | Entracare, LLC | 2006-02-08 | Traditional | PDF ↗ |
| K051059 | AMSURE 100% SILICONE FOLEY CATHETER | Amsino International, Inc. | 2005-06-28 | Traditional | PDF ↗ |
| K042110 | BEAMCATH | Beampoint AB | 2005-02-25 | Traditional | PDF ↗ |
| K042709 | DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER | Tyco Healthcare | 2005-01-18 | Traditional | PDF ↗ |
| K041983 | OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016 | Opticon Medical | 2004-11-17 | Traditional | PDF ↗ |
| K040504 | BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERS | C.R. Bard, Inc. | 2004-05-14 | Traditional | PDF ↗ |
| K033830 | OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000 | Opticon Medical, Inc. | 2004-01-09 | Special | PDF ↗ |
| K030120 | AMSURE FOLEY CATHETER | Amsino International, Inc. | 2003-10-29 | Traditional | PDF ↗ |
| K031748 | VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES | Vitalcare Group, Inc. | 2003-08-27 | Traditional | PDF ↗ |
| K024010 | DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER | The Kendall Company Div. of Tyco Healthcare Group | 2003-06-11 | Traditional | PDF ↗ |
| K030813 | PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND | Primary Care Solutions, Inc. | 2003-05-30 | Traditional | PDF ↗ |
| K021939 | VITALCARE FOLEY CATHETER | Vitalcare, Inc. | 2003-04-22 | Traditional | PDF ↗ |
| K023090 | OPTION-VF URINARY CATHETER, FV14218 | Opticon Medical, Inc. | 2003-03-19 | Traditional | PDF ↗ |
| K021142 | ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865 | Fortune Medical Instrument Corp. | 2002-10-01 | Traditional | PDF ↗ |
| K022287 | 3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS | 3t Medical Systems, LLC | 2002-09-23 | Traditional | PDF ↗ |
| K002612 | BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL 3CC BALLOON: 17008,170010,5CC BALLOON | C.R. Bard, Inc. | 2002-09-03 | Abbreviated | PDF ↗ |
| K013276 | ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE) | Sewoon Medical Co., Ltd. | 2002-02-15 | Traditional | PDF ↗ |
| K013174 | PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL, | Porges S.A. | 2002-01-04 | Abbreviated | PDF ↗ |
| K013172 | PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL | Porges S.A. | 2001-12-20 | Abbreviated | PDF ↗ |
| K010006 | DRAINAGE CATHETER OR FOLEY CATHETER | Applied Medical Resources Corp. | 2001-07-25 | Traditional | PDF ↗ |
| K003784 | MENTOR SELF-CATH PLUS | Mentor Corp. | 2001-03-05 | Traditional | PDF ↗ |
| K003289 | BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED); BARDEX LUBRI-SIL TEMPERATURE-SENSING FOLEY CATHETER (LU | C.R. Bard, Inc. | 2001-01-05 | Abbreviated | PDF ↗ |
| K002868 | BARD ALL-SILICONE 3-WAY FOLEY CATHETER; BARD LUBRI-SIL 3-WAY FOLEY CATHETER; BARD LUBRI-SIL I.C. 3-WAY FOLEY CATHETER | C.R. Bard, Inc. | 2000-12-08 | Abbreviated | PDF ↗ |
| K993063 | RUSCH BRILLANT SILICONE FOLEY | Rusch Intl. | 1999-12-09 | Traditional | PDF ↗ |
| K990500 | KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C | The Kendal Co. | 1999-09-28 | Abbreviated | PDF ↗ |
| K990509 | OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818 | Implemed, Inc. | 1999-05-18 | Abbreviated | PDF ↗ |
| K984084 | BARDEX LUBRI-SIL FOLEY CATHETER | Bard Medical Div. | 1999-02-01 | Traditional | PDF ↗ |
| K982970 | MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER | Mri Manufacturing and Research, Inc. | 1998-10-28 | Traditional | PDF ↗ |
| K973076 | EUROMEDICAL HAEMATURIA FOLEY CATHETER | Unomedical Sdn Bhd | 1998-09-16 | Traditional | PDF ↗ |
| K982626 | URETHROPEXY SUTURE PLACEMENT KIT MODEL NUMBERS UM-300, MW-100, MINI-LAPAROTOMY MMK KIT MODEL UM-250, LAPAROSCOPIC BURCH0 | Medworks Corp. | 1998-08-20 | Special | PDF ↗ |
| K981612 | ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETER | Rochester Medical Corp. | 1998-07-08 | Traditional | PDF ↗ |
| K980870 | RUSCH SILICONE FOLEY CATHETER | Rusch, Inc. | 1998-06-09 | Traditional | PDF ↗ |
| K980919 | ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER | Fortune Medical Instrument Corp. | 1998-03-31 | Traditional | PDF ↗ |
| K974419 | RUSCH SIMPLASTIC COUNCILL TIP CATHETER | Rusch, Inc. | 1998-01-27 | Traditional | PDF ↗ |
| K972184 | RUSCH BRILLANT SILICONE FOLEY CATHETER | Rusch Intl. | 1998-01-08 | Traditional | PDF ↗ |
| K971643 | RUSCH BRILLANT BALLOON CATHETER | Rusch Intl. | 1997-10-07 | Traditional | PDF ↗ |
| K971796 | LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS | Louisville Laboratories, Inc. | 1997-08-12 | Traditional | PDF ↗ |
| K971801 | LAPAROTOMY BLADDER NECK SUSPENSION KIT | Louisville Laboratories, Inc. | 1997-07-22 | Traditional | PDF ↗ |
| K964757 | CONTIDRAIN CATHETER | Contimed, Inc. | 1997-06-25 | Traditional | PDF ↗ |
| K970716 | OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE | Opticon Medical, Inc. | 1997-05-16 | Traditional | PDF ↗ |
Product code EZL · Class II · Gastroenterology, Urology. Data: openFDA.