Catheter, Straight
FDA product code EZD · Class II (moderate risk) · 21 CFR 876.5130 · Gastroenterology, Urology
86510(k) clearances
0PMA approvals
13recalls
Manufacturers
- Coloplast Corp. 12
- ConvaTec, Inc 6
- Hollister, Inc. 5
- C.R. Bard, Inc. 5
- Compactcath, Inc. 3
- Well Lead Medical Co., Ltd. 3
- Wellspect AB 3
- Cure Medical, LLC 3
- Percutaneous Systems, Inc. 2
- Medline Industries, LP 2
- Adapta Medical, Inc. 2
- Amsino International, Inc. 2
- Astra Tech, Inc. 2
- Dentsply Sirona 2
- Mentor Corp. 2
- Chengdu Daxan Innovative Medical Tech. Co., Ltd. 2
- HR Healthcare 2
- Hangzhou Jimushi Meditech Co., Ltd. 2
- Boston Pacific Medical, Inc. 2
- Taylor Catheter Holder Mfg. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260737 | Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure…EZD · Traditional | Convatec | 08/05/2026SE |
| K261658 | LoFric Origo Pro CoudéEZD · Special | Wellspect AB | 07/17/2026SE |
| K262045 | Luja SoftEZD · Special | Coloplast A.S. | 07/07/2026SE |
| K260394 | Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)EZD · Traditional | Hangzhou Jimushi Meditech Co., Ltd. | 06/24/2026SE |
| K253295 | Coude Sleeved IC; Coude Plus Sleeved ICEZD · Traditional | Hollister Incorporated | 05/18/2026SE |
| K260999 | LoFric Elle ProEZD · Special | Wellspect AB | 04/24/2026SE |
| K252943 | GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for WomenEZD · Traditional | Convatec Limited | 04/01/2026SE |
| K260502 | Liv Pre-lubricated Intermittent CatheterEZD · Traditional | HR Healthcare | 03/12/2026SE |
| K251274 | EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic…EZD · Traditional | HR Healthcare | 01/29/2026SESK |
| K251178 | Ready to use Nelaton CatheterEZD · Traditional | Jamjoom Fullcare Corporation | 01/02/2026SE |
| K251468 | Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not…EZD · Traditional | Hollister Incorporated | 10/03/2025SE |
| K250659 | LoFric OrigoEZD · Traditional | Wellspect AB | 09/26/2025SE |
| K250699 | Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist…EZD · Traditional | Convatec | 07/01/2025SE |
| K251116 | Luja CoudéEZD · Traditional | Coloplast Corp. | 06/27/2025SE |
| K243175 | Disposable Intermittent Catheter (TPU Catheter)EZD · Traditional | Chengdu Daxan Innovative Medical Tech. Co., Ltd. | 06/26/2025SE |
| K250270 | Luja SetEZD · Special | Coloplast Corp. | 04/17/2025SE |
| K242049 | SureCath SetEZD · Traditional | Coloplast Corp. | 11/26/2024SE |
| K241210 | Luja CoudeEZD · Traditional | Coloplast Corp. | 11/21/2024SE |
| K241028 | Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)EZD · Traditional | Coloplast | 07/26/2024SE |
| K233524 | Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not…EZD · Traditional | Hollister Incorporated | 05/03/2024SE |
| K232665 | GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for…EZD · Traditional | Convatec | 01/25/2024SE |
| K230400 | Cure Catheter Closed System; Cure Dextra Closed SystemEZD · Traditional | Convatec, Inc. | 11/08/2023SESK |
| K233101 | Luja Coude (20108 Male CH18 - large packaging)EZD · Special | Coloplast Corp. | 10/26/2023SE |
| K230165 | Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10…EZD · Traditional | Coloplast | 08/25/2023SE |
| K220722 | PVC Hydrophilic Urethral CatheterEZD · Traditional | Well Lead Medical Co., Ltd. | 05/22/2023SE |
| K223756 | SimPro Now, GentleCath HydrophilicEZD · Traditional | Dentsply Sirona | 05/04/2023SE |
| K222677 | Intermittent nelaton catheter for single useEZD · Traditional | Hangzhou Jimushi Meditech Co., Ltd. | 04/05/2023SE |
| K220667 | Sleeved ICEZD · Traditional | Hollister Incorporated | 12/08/2022SE |
| K212567 | PVC Hydrophilic Urethral CatheterEZD · Traditional | Chengdu Daxan Innovative Medical Tech. Co., Ltd. | 12/07/2022SE |
| K221401 | Self-Cath and Self-Cath PlusEZD · Traditional | Coloplast | 12/02/2022SE |
| K221593 | Cure Ultra Male, Cure Ultra Female, Cure Ultra PlusEZD · Traditional | Convatec, Inc. | 11/17/2022SE |
| K222059 | SpeediCath Flex SetEZD · Traditional | Coloplast | 09/21/2022SE |
| K213575 | Female IC (Not Finalized)EZD · Traditional | Hollister Incorporated | 09/13/2022SE |
| K212430 | BONREE Nelaton CatheterEZD · Traditional | Bonree Medical Co., Ltd. | 04/29/2022SE |
| K210250 | SpeedCath Compact MaleEZD · Traditional | Coloplast | 04/26/2022SE |
| K203637 | SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812…EZD · Traditional | Coloplast | 03/08/2022SE |
| K211212 | LoFric ElleEZD · Traditional | Dentsply Sirona | 02/17/2022SE |
| K202566 | Wiygul CatheterEZD · Traditional | Big Blue Biotech, Inc. | 09/30/2020SE |
| K181445 | AMSure Hydrophilic Intermittent CatheterEZD · Traditional | Amsino International, Inc. | 10/01/2018SE |
| K180738 | COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary…EZD · Special | Compactcath, Inc. | 06/14/2018SE |
| K172541 | Medline Catheter Specimen CollectorEZD · Traditional | Medline Industries, Inc. | 02/22/2018SE |
| K170233 | Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex…EZD · Traditional | Zhanjiang Star Enterprise Co., Ltd. | 10/13/2017SE |
| K172247 | Magic3 Go Intermittent Urinary CatheterEZD · Traditional | C.R. Bard, Inc. | 09/20/2017SE |
| K161445 | PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro CEZD · Special | Adapta Medical, Inc. | 08/16/2016SE |
| K160858 | CompactCath Intermittent Urinary CatheterEZD · Special | Compactcath, Inc. | 04/26/2016SE |
| K151745 | FULL CARE Disposable PVC Nelaton CatheterEZD · Traditional | Shaoxing Fuqing Health Products Co., Ltd. | 03/03/2016SE |
| K150345 | Magic3 Go Intermittent Urinary CatheterEZD · Traditional | C.R. Bard, Inc. | 05/11/2015SE |
| K142575 | Bard RiteCath Intermittent Urinary CatheterEZD · Traditional | C.R. Bard, Inc. | 10/31/2014SE |
| K142563 | Well Lead PVC Urethral CatheterEZD · Traditional | Well Lead Medical Co., Ltd. | 10/28/2014SE |
| K140945 | Compactcath Intermittent Urinary CatheterEZD · Traditional | Compactcath, Inc. | 08/22/2014SE |
| K133470 | Bard Ritecath Intermittent CatheterEZD · Traditional | C.R. Bard, Inc. | 04/04/2014SE |
| K133615 | Well Lead PVC Hydrophilic Urethral CatheterEZD · Traditional | Well Lead Medical Co., Ltd. | 02/24/2014SE |
| K132500 | Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure Catheter Pediatric…EZD · Special | Cure Medical, LLC | 12/23/2013SE |
| K132619 | Classic Intermittent CatheterEZD · Traditional | Flexicare Medical, Ltd. | 10/11/2013SE |
| K122785 | Hydrosil; Magic; Personal CatheterEZD · Traditional | Rochester Medical Corp. | 05/14/2013SE |
| K123751 | Lofric SenseEZD · Traditional | Wellspect Healthcare | 02/28/2013SE |
| K122078 | Lofric Primo, Lofric Hydro-KitEZD · Traditional | Astra Tech, Inc. | 10/31/2012SE |
| K113424 | Lofric Single Use Urinary CatheterEZD · Traditional | Astra Tech AB | 04/17/2012SE |
| K112137 | Comfortglide Intermitent CatheterEZD · Traditional | C.R. Bard, Inc. | 08/26/2011SESK |
| K110653 | Cure CatheterEZD · Traditional | Cure Medical, LLC | 08/01/2011SE |
| K103086 | Dynarex Intermittent Catheters, Male, Female, PediatricEZD · Traditional | Dynarex Corporation | 06/07/2011SE |
| K103043 | Colorado Catheter Sterilesure - New Name Perfic CathEZD · Traditional | Adapta Medical, Inc. | 01/07/2011SE |
| K100302 | Medline PVC Urethral CatheterEZD · Traditional | Medline Industries, Inc. | 07/02/2010SE |
| K100878 | Self Cath CatheterEZD · Traditional | Coloplast Manufacturing Us, LLC | 05/26/2010SE |
| K091306 | Amsure PVC Intermittent CatheterEZD · Special | Amsino International, Inc. | 08/21/2009SE |
| K090576 | Footprint Urinary Drainage CatheterEZD · Traditional | Footprint Medical | 08/12/2009SE |
| K080007 | Graduated Adapter with ClaveEZD · Traditional | Icu Medical, Inc. | 05/13/2008SE |
| K072997 | Neomed Urinary CatheterEZD · Traditional | Neomed, Inc. | 12/19/2007SE |
| K072539 | Cure CatheterEZD · Traditional | Cure Medical, LLC | 09/13/2007SE |
| K061766 | Expressway Intermittent CatheterEZD · Traditional | Percutaneous Systems, Incorporated | 03/09/2007SE |
| K062444 | Hi-Slip and Hi-Slip Plus Single Use Hydrophilic Urinary Catheters and KitEZD · Traditional | Oasis Medikal Urunler Kimya Sanayi VE Tic A.S. | 02/22/2007SE |
| K052440 | Mentor Self-Cath Hydrogel Intermittent CatheterEZD · Special | Mentor Corporation | 10/11/2005SE |
| K050008 | Mentor Self-Cath Hydrogel Intermittent CatheterEZD · Traditional | Mentor Corp. | 06/03/2005SE |
| K041464 | Busse Hospital Disposables Urethral CatheterEZD · Traditional | Busse Hospital Disposables | 11/05/2004SE |
| K040519 | Slip Urology CatheterEZD · Traditional | Percutaneous Systems, Inc. | 05/20/2004SE |
| K023872 | Vitalcare Urethral Catheter Red RubberEZD · Traditional | Vitalcare, Inc. | 04/10/2003SE |
| K030538 | American Catheter, Model W3EZD · Traditional | Catheter, LLC | 03/10/2003SE |
| K993226 | Memcath Urology Catheter, Model 101 -000 - 006EZD · Traditional | Memcath Technologies, LLC | 12/10/1999SE |
| K973546 | Kendall Fast-Cath Pre Lubricated Urethral CatheterEZD · Traditional | Kendall Healthcare Products Co. Div.Of Tyco Health | 11/07/1997SE |
| K973070 | Conveen Easicath SetEZD · Traditional | Coloplast Corp. | 11/06/1997SE |
| K944383 | Orion Red Urethral CatheterEZD · Traditional | Regulatory & Marketing Services, Inc. | 12/06/1994SE |
| K944782 | Catco Urological CatheterEZD · Traditional | Catco Medical, Inc. | 10/13/1994SE |
| K923848 | Goosen Self-Lubricating CatheterEZD · Traditional | Goosen Enterprises, Inc. | 02/18/1994SE |
| K931048 | 4-SURE Nelaton CatheterEZD · Traditional | Boston Pacific Medical, Inc. | 02/14/1994SE |
| K931047 | 4-SURE Female CatheterEZD · Traditional | Boston Pacific Medical, Inc. | 02/14/1994SE |
| K780411 | Taylor Catheter HolderEZD · Traditional | Taylor Catheter Holder Mfg. | 04/13/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1701-2023 Class II | HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810…Some catheters had a manufacturing defect where the clear resealing label separating from the product foil… | C.R. Bard Inc | 04/20/2023Open, Classified |
| Z-1700-2023 Class II | Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810GSome catheters had a manufacturing defect where the clear resealing label separating from the product foil… | C.R. Bard Inc | 04/20/2023Open, Classified |
| Z-1699-2023 Class II | Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G, b) REF…Some catheters had a manufacturing defect where the clear resealing label separating from the product foil… | C.R. Bard Inc | 04/20/2023Open, Classified |
| Z-1698-2023 Class II | Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, b) REF…Some catheters had a manufacturing defect where the clear resealing label separating from the product foil… | C.R. Bard Inc | 04/20/2023Open, Classified |
| Z-2645-2020 Class II | LoFric Origo, Tiemann, 16in, FR14 urinary cathetersWellspect Healthcare is voluntarily recalling certain LoFric Origo" urethral catheters due to a potential… | Wellspect HealthCare (Division of DENTSPLY… | 06/17/2020Terminated |
| Z-2644-2020 Class II | LoFric Origo, Tiemann, 16in, FR12 urinary cathetersWellspect Healthcare is voluntarily recalling certain LoFric Origo" urethral catheters due to a potential… | Wellspect HealthCare (Division of DENTSPLY… | 06/17/2020Terminated |
| Z-2643-2020 Class II | LoFric Origo, Nelaton, 16in, FR10 urinary cathetersWellspect Healthcare is voluntarily recalling certain LoFric Origo" urethral catheters due to a potential… | Wellspect HealthCare (Division of DENTSPLY… | 06/17/2020Terminated |
| Z-1309-2018 Class II | Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, each…Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were… | C.R. Bard, Inc. | 09/14/2017Terminated |
| Z-1308-2018 Class II | Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter is…Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were… | C.R. Bard, Inc. | 09/14/2017Terminated |
| Z-1307-2018 Class II | HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each…Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were… | C.R. Bard, Inc. | 09/14/2017Terminated |
| Z-0496-2015 Class II | Pediatric, 10Fr, Intermittent Urinary Catheters Model: P10 Pouch Label UPC (P10)…Some of the intermediate boxes within lot 140417-3, were labeled as P8, a French Size 8 pediatric catheter… | Cure Medical LLC | 11/11/2014Terminated |
| Z-0004-2013 Class II | Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed…The firm initiated the product recall because labeling on some of the intermediate boxes of catheters… | Cure Medical LLC | 09/19/2012Terminated |
| Z-2409-2011 | SureCath Set with Accessories, Coloplast Corp.-MN 06093, Sterile EO., Manufacturer…Coloplast has initiated a recall on SpeediCath with Insertion Supplies and SureCath Set with Insertion… | Coloplast Manufacturing US, LLC | 04/21/2011Terminated |