FDA Product Code
FDA Product Code EZD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5130
510(k) Clearances — 87 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261418 | Liquick X-treme, Liquick X-treme Plus | Teleflex Medical | 2026-09-23 | Traditional | PDF ↗ |
| K260737 | Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18). | Convatec | 2026-08-05 | Traditional | PDF ↗ |
| K261658 | LoFric Origo Pro Coudé | Wellspect AB | 2026-07-17 | Special | PDF ↗ |
| K262045 | Luja Soft | Coloplast A.S. | 2026-07-07 | Special | PDF ↗ |
| K260394 | Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) | Hangzhou Jimushi Meditech Co., Ltd. | 2026-06-24 | Traditional | PDF ↗ |
| K253295 | Coude Sleeved IC; Coude Plus Sleeved IC | Hollister Incorporated | 2026-05-18 | Traditional | PDF ↗ |
| K260999 | LoFric Elle Pro | Wellspect AB | 2026-04-24 | Special | PDF ↗ |
| K252943 | GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women | Convatec Limited | 2026-04-01 | Traditional | PDF ↗ |
| K260502 | Liv Pre-lubricated Intermittent Catheter | HR Healthcare | 2026-03-12 | Traditional | PDF ↗ |
| K251274 | EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits | HR Healthcare | 2026-01-29 | Traditional | PDF ↗ |
| K251178 | Ready to use Nelaton Catheter | Jamjoom Fullcare Corporation | 2026-01-02 | Traditional | PDF ↗ |
| K251468 | Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A) | Hollister Incorporated | 2025-10-03 | Traditional | PDF ↗ |
| K250659 | LoFric Origo | Wellspect AB | 2025-09-26 | Traditional | PDF ↗ |
| K250699 | 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 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K) | Convatec | 2025-07-01 | Traditional | PDF ↗ |
| K251116 | Luja Coudé | Coloplast Corp. | 2025-06-27 | Traditional | PDF ↗ |
| K243175 | Disposable Intermittent Catheter (TPU Catheter) | Chengdu Daxan Innovative Medical Tech. Co., Ltd. | 2025-06-26 | Traditional | PDF ↗ |
| K250270 | Luja Set | Coloplast Corp. | 2025-04-17 | Special | PDF ↗ |
| K242049 | SureCath Set | Coloplast Corp. | 2024-11-26 | Traditional | PDF ↗ |
| K241210 | Luja Coude | Coloplast Corp. | 2024-11-21 | Traditional | PDF ↗ |
| K241028 | Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) | Coloplast | 2024-07-26 | Traditional | PDF ↗ |
| K233524 | 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) | Hollister Incorporated | 2024-05-03 | Traditional | PDF ↗ |
| K232665 | GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) | Convatec | 2024-01-25 | Traditional | PDF ↗ |
| K230400 | Cure Catheter Closed System; Cure Dextra Closed System | Convatec, Inc. | 2023-11-08 | Traditional | PDF ↗ |
| K233101 | Luja Coude (20108 Male CH18 - large packaging) | Coloplast Corp. | 2023-10-26 | Special | PDF ↗ |
| K230165 | Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging) | Coloplast | 2023-08-25 | Traditional | PDF ↗ |
| K220722 | PVC Hydrophilic Urethral Catheter | Well Lead Medical Co., Ltd. | 2023-05-22 | Traditional | PDF ↗ |
| K223756 | SimPro Now, GentleCath Hydrophilic | Dentsply Sirona | 2023-05-04 | Traditional | PDF ↗ |
| K222677 | Intermittent nelaton catheter for single use | Hangzhou Jimushi Meditech Co., Ltd. | 2023-04-05 | Traditional | PDF ↗ |
| K220667 | Sleeved IC | Hollister Incorporated | 2022-12-08 | Traditional | PDF ↗ |
| K212567 | PVC Hydrophilic Urethral Catheter | Chengdu Daxan Innovative Medical Tech. Co., Ltd. | 2022-12-07 | Traditional | PDF ↗ |
| K221401 | Self-Cath and Self-Cath Plus | Coloplast | 2022-12-02 | Traditional | PDF ↗ |
| K221593 | Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus | Convatec, Inc. | 2022-11-17 | Traditional | PDF ↗ |
| K222059 | SpeediCath Flex Set | Coloplast | 2022-09-21 | Traditional | PDF ↗ |
| K213575 | Female IC (Not Finalized) | Hollister Incorporated | 2022-09-13 | Traditional | PDF ↗ |
| K212430 | BONREE Nelaton Catheter | Bonree Medical Co., Ltd. | 2022-04-29 | Traditional | PDF ↗ |
| K210250 | SpeedCath Compact Male | Coloplast | 2022-04-26 | Traditional | PDF ↗ |
| K203637 | SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814) | Coloplast | 2022-03-08 | Traditional | PDF ↗ |
| K211212 | LoFric Elle | Dentsply Sirona | 2022-02-17 | Traditional | PDF ↗ |
| K202566 | Wiygul Catheter | Big Blue Biotech, Inc. | 2020-09-30 | Traditional | PDF ↗ |
| K181445 | AMSure Hydrophilic Intermittent Catheter | Amsino International, Inc. | 2018-10-01 | Traditional | PDF ↗ |
| K180738 | COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter | Compactcath, Inc. | 2018-06-14 | Special | PDF ↗ |
| K172541 | Medline Catheter Specimen Collector | Medline Industries, Inc. | 2018-02-22 | Traditional | PDF ↗ |
| K170233 | Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter) | Zhanjiang Star Enterprise Co., Ltd. | 2017-10-13 | Traditional | PDF ↗ |
| K172247 | Magic3 Go Intermittent Urinary Catheter | C.R. Bard, Inc. | 2017-09-20 | Traditional | PDF ↗ |
| K161445 | PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C | Adapta Medical, Inc. | 2016-08-16 | Special | PDF ↗ |
| K160858 | CompactCath Intermittent Urinary Catheter | Compactcath, Inc. | 2016-04-26 | Special | PDF ↗ |
| K151745 | FULL CARE Disposable PVC Nelaton Catheter | Shaoxing Fuqing Health Products Co., Ltd. | 2016-03-03 | Traditional | PDF ↗ |
| K150345 | Magic3 Go Intermittent Urinary Catheter | C.R. Bard, Inc. | 2015-05-11 | Traditional | PDF ↗ |
| K142575 | Bard RiteCath Intermittent Urinary Catheter | C.R. Bard, Inc. | 2014-10-31 | Traditional | PDF ↗ |
| K142563 | Well Lead PVC Urethral Catheter | Well Lead Medical Co., Ltd. | 2014-10-28 | Traditional | PDF ↗ |
| K140945 | COMPACTCATH INTERMITTENT URINARY CATHETER | Compactcath, Inc. | 2014-08-22 | Traditional | PDF ↗ |
| K133470 | BARD RITECATH INTERMITTENT CATHETER | C.R. Bard, Inc. | 2014-04-04 | Traditional | PDF ↗ |
| K133615 | WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER | Well Lead Medical Co., Ltd. | 2014-02-24 | Traditional | PDF ↗ |
| K132500 | CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED | Cure Medical, LLC | 2013-12-23 | Special | PDF ↗ |
| K132619 | CLASSIC INTERMITTENT CATHETER | Flexicare Medical, Ltd. | 2013-10-11 | Traditional | PDF ↗ |
| K122785 | HYDROSIL; MAGIC; PERSONAL CATHETER | Rochester Medical Corp. | 2013-05-14 | Traditional | PDF ↗ |
| K123751 | LOFRIC SENSE | Wellspect Healthcare | 2013-02-28 | Traditional | PDF ↗ |
| K122078 | LOFRIC PRIMO, LOFRIC HYDRO-KIT | Astra Tech, Inc. | 2012-10-31 | Traditional | PDF ↗ |
| K113424 | LOFRIC SINGLE USE URINARY CATHETER | Astra Tech AB | 2012-04-17 | Traditional | PDF ↗ |
| K112137 | COMFORTGLIDE INTERMITENT CATHETER | C.R. Bard, Inc. | 2011-08-26 | Traditional | PDF ↗ |
| K110653 | CURE CATHETER | Cure Medical, LLC | 2011-08-01 | Traditional | PDF ↗ |
| K103086 | DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC | Dynarex Corporation | 2011-06-07 | Traditional | PDF ↗ |
| K103043 | COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATH | Adapta Medical, Inc. | 2011-01-07 | Traditional | PDF ↗ |
| K100302 | MEDLINE PVC URETHRAL CATHETER | Medline Industries, Inc. | 2010-07-02 | Traditional | PDF ↗ |
| K100878 | SELF CATH CATHETER | Coloplast Manufacturing Us, LLC | 2010-05-26 | Traditional | PDF ↗ |
| K091306 | AMSURE PVC INTERMITTENT CATHETER | Amsino International, Inc. | 2009-08-21 | Special | PDF ↗ |
| K090576 | FOOTPRINT URINARY DRAINAGE CATHETER | Footprint Medical | 2009-08-12 | Traditional | PDF ↗ |
| K080007 | GRADUATED ADAPTER WITH CLAVE | Icu Medical, Inc. | 2008-05-13 | Traditional | PDF ↗ |
| K072997 | NEOMED URINARY CATHETER | Neomed, Inc. | 2007-12-19 | Traditional | PDF ↗ |
| K072539 | CURE CATHETER | Cure Medical, LLC | 2007-09-13 | Traditional | PDF ↗ |
| K061766 | EXPRESSWAY INTERMITTENT CATHETER | Percutaneous Systems, Incorporated | 2007-03-09 | Traditional | PDF ↗ |
| K062444 | HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CATHETERS AND KIT | Oasis Medikal Urunler Kimya Sanayi VE Tic A.S. | 2007-02-22 | Traditional | PDF ↗ |
| K052440 | MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER | Mentor Corporation | 2005-10-11 | Special | PDF ↗ |
| K050008 | MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER | Mentor Corp. | 2005-06-03 | Traditional | PDF ↗ |
| K041464 | BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER | Busse Hospital Disposables | 2004-11-05 | Traditional | PDF ↗ |
| K040519 | SLIP UROLOGY CATHETER | Percutaneous Systems, Inc. | 2004-05-20 | Traditional | PDF ↗ |
| K023872 | VITALCARE URETHRAL CATHETER RED RUBBER | Vitalcare, Inc. | 2003-04-10 | Traditional | PDF ↗ |
| K030538 | AMERICAN CATHETER, MODEL W3 | Catheter, LLC | 2003-03-10 | Traditional | PDF ↗ |
| K993226 | MEMCATH UROLOGY CATHETER, MODEL 101 -000 - 006 | Memcath Technologies, LLC | 1999-12-10 | Traditional | PDF ↗ |
| K973546 | KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER | Kendall Healthcare Products Co. Div.Of Tyco Health | 1997-11-07 | Traditional | PDF ↗ |
| K973070 | CONVEEN EASICATH SET | Coloplast Corp. | 1997-11-06 | Traditional | PDF ↗ |
| K944383 | ORION RED URETHRAL CATHETER | Regulatory & Marketing Services, Inc. | 1994-12-06 | Traditional | PDF ↗ |
| K944782 | CATCO UROLOGICAL CATHETER | Catco Medical, Inc. | 1994-10-13 | Traditional | PDF ↗ |
| K923848 | GOOSEN SELF-LUBRICATING CATHETER | Goosen Enterprises, Inc. | 1994-02-18 | Traditional | PDF ↗ |
| K931047 | 4-SURE FEMALE CATHETER | Boston Pacific Medical, Inc. | 1994-02-14 | Traditional | PDF ↗ |
| K931048 | 4-SURE NELATON CATHETER | Boston Pacific Medical, Inc. | 1994-02-14 | Traditional | PDF ↗ |
| K780411 | TAYLOR CATHETER HOLDER | Taylor Catheter Holder Mfg. | 1978-04-13 | Traditional | PDF ↗ |
Product code EZD · Class II · Gastroenterology, Urology. Data: openFDA.