FDA 510(k) Applications for Medical Device Product Code "EZD"
(Catheter, Straight)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K103043 | ADAPTA MEDICAL, INC | COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATH | 01/07/2011 |
| K161445 | ADAPTA MEDICAL, INC | PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C | 08/16/2016 |
| K181445 | Amsino International Inc. | AMSure Hydrophilic Intermittent Catheter | 10/01/2018 |
| K091306 | AMSINO INTERNATIONAL, INC. | AMSURE PVC INTERMITTENT CATHETER | 08/21/2009 |
| K113424 | ASTRA TECH AB | LOFRIC SINGLE USE URINARY CATHETER | 04/17/2012 |
| K122078 | ASTRA TECH, INC. | LOFRIC PRIMO, LOFRIC HYDRO-KIT | 10/31/2012 |
| K202566 | Big Blue Biotech, Inc. | Wiygul Catheter | 09/30/2020 |
| K212430 | Bonree Medical Co., Ltd | BONREE Nelaton Catheter | 04/29/2022 |
| K041464 | BUSSE HOSPITAL DISPOSABLES | BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER | 11/05/2004 |
| K133470 | C.R. BARD, INC. | BARD RITECATH INTERMITTENT CATHETER | 04/04/2014 |
| K142575 | C.R. Bard, Inc. | Bard RiteCath Intermittent Urinary Catheter | 10/31/2014 |
| K112137 | C.R. BARD, INC. | COMFORTGLIDE INTERMITENT CATHETER | 08/26/2011 |
| K150345 | C.R. BARD, INC. | Magic3 Go Intermittent Urinary Catheter | 05/11/2015 |
| K172247 | C.R. Bard, Inc. | Magic3 Go Intermittent Urinary Catheter | 09/20/2017 |
| K030538 | CATHETER LLC. | AMERICAN CATHETER, MODEL W3 | 03/10/2003 |
| K212567 | Chengdu Daxan Innovative Medical Tech. Co., Ltd | PVC Hydrophilic Urethral Catheter | 12/07/2022 |
| K230165 | Coloplast | Luja CoudΘ (20118 Male CH8 - small packaging (Pocket size)), Luja CoudΘ (20111 Male CH10 - small packaging (Pocket size)), Luja CoudΘ (20112 Male CH12 - small packaging (Pocket size)), Luja CoudΘ (20114 Male CH14 - small packaging (Pocket size)), Luja Cou | 08/25/2023 |
| K241028 | Coloplast | Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) | 07/26/2024 |
| K221401 | Coloplast | Self-Cath and Self-Cath Plus | 12/02/2022 |
| K210250 | Coloplast | SpeedCath Compact Male | 04/26/2022 |
| K203637 | Coloplast | SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814) | 03/08/2022 |
| K222059 | Coloplast | SpeediCath Flex Set | 09/21/2022 |
| K241210 | Coloplast Corp | Luja Coude | 11/21/2024 |
| K233101 | Coloplast Corp | Luja Coude (20108 Male CH18 - large packaging) | 10/26/2023 |
| K250270 | Coloplast Corp | Luja Set | 04/17/2025 |
| K242049 | Coloplast Corp | SureCath Set | 11/26/2024 |
| K973070 | COLOPLAST CORP. | CONVEEN EASICATH SET | 11/06/1997 |
| K251116 | Coloplast Corp. | Luja CoudΘ | 06/27/2025 |
| K100878 | COLOPLAST MANUFACTURING US, LLC | SELF CATH CATHETER | 05/26/2010 |
| K140945 | COMPACTCATH INC | COMPACTCATH INTERMITTENT URINARY CATHETER | 08/22/2014 |
| K160858 | COMPACTCATH INC. | CompactCath Intermittent Urinary Catheter | 04/26/2016 |
| K180738 | Compactcath, Inc. | COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter | 06/14/2018 |
| K250699 | Convatec | Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female | 07/01/2025 |
| K232665 | ConvaTec | GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) | 01/25/2024 |
| K230400 | ConvaTec, Inc. | Cure Catheter Closed System; Cure Dextra Closed System | 11/08/2023 |
| K221593 | ConvaTec, Inc. | Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus | 11/17/2022 |
| K072539 | CURE MEDICAL LLC. | CURE CATHETER | 09/13/2007 |
| K110653 | CURE MEDICAL LLC. | CURE CATHETER | 08/01/2011 |
| K132500 | CURE MEDICAL LLC. | CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED | 12/23/2013 |
| K211212 | Dentsply Sirona | LoFric Elle | 02/17/2022 |
| K223756 | Dentsply Sirona | SimProÖ Now, GentleCathÖ Hydrophilic | 05/04/2023 |
| K103086 | DYNAREX CORPORATION | DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC | 06/07/2011 |
| K132619 | FLEXICARE MEDICAL LTD. | CLASSIC INTERMITTENT CATHETER | 10/11/2013 |
| K090576 | FOOTPRINT MEDICAL | FOOTPRINT URINARY DRAINAGE CATHETER | 08/12/2009 |
| K222677 | Hangzhou Jimushi Meditech Co., Ltd. | Intermittent nelaton catheter for single use | 04/05/2023 |
| K213575 | Hollister Incorporated | Female IC (Not Finalized) | 09/13/2022 |
| K220667 | Hollister Incorporated | Sleeved IC | 12/08/2022 |
| K233524 | Hollister Incorporated | Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized) | 05/03/2024 |
| K080007 | ICU MEDICAL, INC | GRADUATED ADAPTER WITH CLAVE | 05/13/2008 |
| K973546 | KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH | KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER | 11/07/1997 |
| K172541 | Medline Industries, Inc. | Medline Catheter Specimen Collector | 02/22/2018 |
| K100302 | MEDLINE INDUSTRIES, INC. | MEDLINE PVC URETHRAL CATHETER | 07/02/2010 |
| K993226 | MEMCATH TECHNOLOGIES LLC. | MEMCATH UROLOGY CATHETER, MODEL 101 -000 - 006 | 12/10/1999 |
| K050008 | MENTOR CORP. | MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER | 06/03/2005 |
| K052440 | MENTOR CORPORATION | MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER | 10/11/2005 |
| K072997 | NEOMED, INC. | NEOMED URINARY CATHETER | 12/19/2007 |
| K062444 | OASIS MEDIKAL URUNLER KIMYA SANAYI VE TIC A.S. | HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CATHETERS AND KIT | 02/22/2007 |
| K040519 | PERCUTANEOUS SYSTEMS, INC. | SLIP UROLOGY CATHETER | 05/20/2004 |
| K061766 | PERCUTANEOUS SYSTEMS, INCORPORATED | EXPRESSWAY INTERMITTENT CATHETER | 03/09/2007 |
| K122785 | ROCHESTER MEDICAL CORP. | HYDROSIL; MAGIC; PERSONAL CATHETER | 05/14/2013 |
| K151745 | SHAOXING FUQING HEALTH PRODUCTS CO., LTD. | FULL CARE Disposable PVC Nelaton Catheter | 03/03/2016 |
| K023872 | VITALCARE, INC. | VITALCARE URETHRAL CATHETER RED RUBBER | 04/10/2003 |
| K133615 | WELL LEAD MEDICAL CO. LTD | WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER | 02/24/2014 |
| K220722 | Well Lead Medical Co., Ltd. | PVC Hydrophilic Urethral Catheter | 05/22/2023 |
| K142563 | WELL LEAD MEDICAL CO., LTD. | Well Lead PVC Urethral Catheter | 10/28/2014 |
| K123751 | WELLSPECT HEALTHCARE | LOFRIC SENSE | 02/28/2013 |
| K170233 | Zhanjiang Star Enterprise Co., Ltd | Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter) | 10/13/2017 |
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