Catheter, Urethral
FDA product code GBM · Class II (moderate risk) · 21 CFR 876.5130 · Gastroenterology, Urology
71510(k) clearances
0PMA approvals
11recalls
Manufacturers
- Hollister, Inc. 11
- Coloplast Corp. 10
- Astra Tech, Inc. 3
- B. Braun Medical, Inc. 3
- Coloplast A/S 3
- C.R. Bard, Inc. 3
- Rochester Medical Corp 2
- Hakki Medical Technologies, Inc. 2
- Hangzhou Bever Medical Devices Co., Ltd. 2
- ConvaTec, Inc 2
- The Kendal Co. 2
- Gesco Intl., Inc. 1
- Asia Dynamics, Inc. 1
- A+ Products 1
- Boston Scientific Corporation 1
- American Medical Systems, Inc. 1
- Transinternational Marketing Group 1
- Sc Hennig Enterprises Europe Srl 1
- Advanced Surgical Intervention, Inc. 1
- Well Lead Medical Co., Ltd. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241734 | Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic…GBM · Traditional | Well Lead Medical Co., Ltd. | 03/05/2025SE |
| K213283 | GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterGBM · Traditional | Convatec Limited | 06/22/2022SE |
| K211436 | Intermittent Catheter (Not Finalized)GBM · Traditional | Hollister Incorporated | 01/27/2022SE |
| K200820 | SpeediCath Compact SetGBM · Traditional | Coloplast | 11/13/2020SE |
| K192904 | SpeediCath Compact SetGBM · Traditional | Coloplast | 11/02/2020SE |
| K200142 | SpeediCath SoftGBM · Traditional | Coloplast | 07/30/2020SE |
| K200134 | Jimushi Sterile Urethral Catheter for single useGBM · Traditional | Hangzhou Jimushi Meditech Co., Ltd. | 06/01/2020SE |
| K191512 | LotusCatheter (Lotus No Balloon Catheter)GBM · Traditional | Hakki Medical Technologies, Inc. | 05/21/2020SESK |
| K192577 | Actreen Hi-Lite Intermittent Urinary CathetersGBM · Special | B.Braun Medical, Inc. | 05/07/2020SE |
| K193148 | VaPro Plus Pocket, VaPro PlusGBM · Special | Hollister Incorporated | 12/13/2019SE |
| K192468 | Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use…GBM · Traditional | Hangzhou Bever Medical Devices Co., Ltd. | 11/27/2019SE |
| K191633 | Infyna ChicGBM · Special | Hollister Incorporated | 07/19/2019SE |
| K190620 | SpeediCath Flex Coude ProGBM · Traditional | Coloplast | 07/10/2019SE |
| K183335 | Medline Poly-Cath Red Polymer Urethral CatheterGBM · Traditional | Medline Industries, Inc. | 06/12/2019SE |
| K183461 | Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent…GBM · Traditional | Teleflexmedical, Inc. | 05/08/2019SESK |
| K182511 | SimplCathGBM · Traditional | F&S Medical Solutions, LLC | 03/20/2019SE |
| K183253 | ValPro 2 Plus, VaPro 2 Plus PocketGBM · Special | Hollister Incorporated | 12/18/2018SE |
| K180801 | Actreen Hi-Lite Cath, Actreen Hi-Lite SetGBM · Traditional | B.Braun Medical, Inc. | 11/05/2018SE |
| K180258 | SpeediCath StandardGBM · Traditional | Coloplast | 10/25/2018SE |
| K181206 | GentleCath Glide Intermittent Urinary CatheterGBM · Traditional | Convatec Limited | 08/16/2018SE |
| K180824 | VaPro 2 Intermittent CatheterGBM · Special | Hollister Incorporated | 06/22/2018SE |
| K180070 | SpeediCath Flex Coude ProGBM · Special | Coloplast | 02/02/2018SE |
| K172278 | Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral StentGBM · Traditional | Cook Incorporated | 11/22/2017SE |
| K163179 | Onli Intermittent CatheterGBM · Special | Hollister Incorporated | 01/26/2017SE |
| K161672 | SpeediCath Flex CoudeGBM · Traditional | Coloplast Corp. | 09/29/2016SE |
| K160795 | United Urologics Intermittent CatheterGBM · Traditional | Robling Medical | 06/16/2016SE |
| K151772 | Actreen Mini Intermittent Urinary CathetersGBM · Traditional | B.Braun Medical, Inc. | 02/09/2016SE |
| K152268 | VAPRO PLUS POCKET Intermittent CatheterGBM · Special | Hollister Incorporated | 09/09/2015SE |
| K150935 | SpeediCath Compact EveGBM · Traditional | Coloplast A/S | 07/02/2015SE |
| K142767 | ThinkMed Intermittent Catheter with/without Hydrophilic CoatingGBM · Traditional | Thinkmed Medical Technology Co., Ltd. | 02/03/2015SE |
| K143182 | Speedicath Compact MaleGBM · Traditional | Coloplast A/S | 01/20/2015SE |
| K143594 | VaPro PocketGBM · Special | Hollister Incorporated | 01/09/2015SE |
| K141642 | Vapro Intermittent CatheterGBM · Special | Hollister Incorporated | 08/22/2014SE |
| K121457 | Speedicath Compact Set (12 FR)GBM · Traditional | Coloplast Corp. | 10/02/2012SE |
| K121458 | Speedicath Compact Set (12/18 FR)GBM · Traditional | Coloplast A/S | 10/01/2012SE |
| K111405 | Bever Unocated / Coated, Paediatric / Male / Female Nelaton-Tip / Tiemann-Tip…GBM · Traditional | Hangzhou Bever Medical Devices Co., Ltd. | 02/13/2012SE |
| K110862 | Vapro Plus Intermittent CatheterGBM · Special | Hollister Incorporated | 04/26/2011SE |
| K101900 | Hakki Urinary Catheter; Size 14, 16, 18, 20, 22, 24, 26 FrenchGBM · Traditional | Hakki Medical Technologies, Inc. | 02/07/2011SE |
| K090960 | Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064, 72084…GBM · Traditional | Hollister, Inc. | 08/20/2009SE |
| K072808 | Speedicath CompactGBM · Traditional | Coloplast Corp. | 11/09/2007SE |
| K063795 | Guardiancatheter-Urinary Drainage CatheterGBM · Traditional | Marian Medical, Inc. | 03/05/2007SE |
| K060268 | Pediatric Urinary CatheterGBM · Traditional | Clay Kennard | 02/24/2006SE |
| K050874 | Astra Tech AB Lofric Primo Single Use Urinary CatheterGBM · Special | Astra Tech, Inc. | 05/05/2005SE |
| K043241 | Lofric Hydro-Kit II Single Use Urinary CatheterGBM · Special | Astra Tech, Inc. | 12/23/2004SE |
| K031409 | Urinary CathetersGBM · Traditional | Promedic, Inc. | 06/17/2003SE |
| K021938 | Vitalcare Urethral CatheterGBM · Traditional | Vitalcare, Inc. | 04/22/2003SE |
| K023254 | SpeedicathGBM · Traditional | Coloplast Corp. | 01/27/2003SE |
| K020714 | Rusch Floneil; Flocath IntrogelGBM · Traditional | Rusch Intl. | 07/01/2002SE |
| K012374 | Modification to: Lofric Plus Single Use Urinary CatheterGBM · Special | Astra Tech, Inc. | 08/23/2001SE |
| K011552 | Urological CatheterGBM · Traditional | Apogee Medical, Inc. | 07/18/2001SE |
| K993651 | O'Neil Sterile Field Intermittent Urinary CatheterGBM · Traditional | Sc Hennig Enterprises Europe Srl | 12/23/1999SE |
| K992137 | Urological CatheterGBM · Traditional | Apogee, Inc. | 09/03/1999SE |
| K973120 | Readycath CatheterGBM · Traditional | Medical Technologies of Georgia | 02/25/1998SE |
| K970704 | Personal CatheterGBM · Traditional | Rochester Medical Corp. | 03/13/1997SE |
| K965067 | Dilation Catheter, BalloonGBM · Traditional | Boston Scientific Corp | 01/28/1997SE |
| K961361 | Asta-CathGBM · Traditional | A+ Products | 10/31/1996SE |
| K952924 | Adi Catheter with ValveGBM · Traditional | Asia Dynamics, Inc. | 08/18/1995SE |
| K943851 | All Silicone Intermittent CatheterGBM · Traditional | Rochester Medical Corp. | 01/31/1995SE |
| K941672 | Uri-Cath CatheterGBM · Traditional | Gesco Intl., Inc. | 05/16/1994SE |
| K926369 | Walther Catheters, Male, FemaleGBM · Traditional | Thomasville Medical Assoc. | 05/21/1993SE |
| K914905 | Entrac(Tm) Urethral Measuring CatheterGBM · Traditional | American Medical Systems, Inc. | 03/20/1992SE |
| K910876 | Autocath(Tm) SetGBM · Traditional | Cook Urological, Inc. | 05/28/1991SE |
| K901441 | Albert Morton Urological CatheterGBM · Traditional | Transinternational Marketing Group | 06/22/1990SE |
| K901336 | Asi Hemostasis CatheterGBM · Traditional | Advanced Surgical Intervention, Inc. | 06/20/1990SE |
| K892442 | Kendall Curity Urethral CathetersGBM · Traditional | The Kendal Co. | 06/23/1989SE |
| K881667 | Kendall Curity & Kenguard Red Rubber Urethral CathGBM · Traditional | The Kendal Co. | 08/12/1988SE |
| K871999 | MMG Uro-Self CatheterGBM · Traditional | Medical Marketing Group | 08/25/1987SE |
| K830840 | Open Ended Ureteral CatheterGBM · Traditional | Van-Tec, Inc. | 04/06/1983SE |
| K760254 | Tray, Foley CatheterGBM · Traditional | C.R. Bard, Inc. | 08/23/1976SE |
| K760253 | Tray, Universal Foly Wo/Drainage BagGBM · Traditional | C.R. Bard, Inc. | 08/23/1976SE |
| K760093 | Catheter, Silicone Foley (Bardex)GBM · Traditional | C.R. Bard, Inc. | 08/23/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2998-2026 Class II | Onli 17cm Hydrophilic Urethral Intermittent Catheter, labeled as: 1) 82081 Ch08-17 Onli…Hollister has identified that select lots of the catheters identified in the above table may exhibit a… | Hollister Ulc | 07/14/2026Open, Classified |
| Z-1061-2026 Class II | BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF:…Labeling error, Incorrect expiration date | Hangzhou Bever Medical Devices Co., Ltd. | 11/29/2025Open, Classified |
| Z-1051-2024 Class I | Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML…Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse… | Cardinal Health 200, LLC | 12/04/2023Open, Classified |
| Z-2533-2021 Class II | Catalog A897514, SureStep" Foley Tray, Silicone, Drainage Bag, StatLock" Stabilization…There is potential for packaging defects that may impact the sterile barrier. | C.R. Bard Inc | 08/05/2021Open, Classified |
| Z-1369-2018 Class II | Simplastic Suprapubic Puncture Instruments: Product Code Equivalent Code (a) 650704100…These products contain latex, but the following statement is not included on any level of product packaging:… | Teleflex Medical Europe Ltd | 03/15/2018Terminated |
| Z-2410-2011 | SpeediCath , SpeediCath with Accessories Coloplast Corp -MN, Sterile R, Manufacturer…Coloplast has initiated a recall on SpeediCath with Insertion Supplies and SureCath Set with Insertion… | Coloplast Manufacturing US, LLC | 04/21/2011Terminated |
| Z-2394-2008 | Apogee Intermittent Catheter with Coude tip, 14 Fr 16", Catalog/Ref No.1066, Sterile…Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to… | Apogee Medical, Inc | 07/17/2008Terminated |
| Z-2393-2008 | Apogee Intermittent Catheter with Coude tip, 12 Fr 16", Catalog/Ref No. 1036, Sterile…Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to… | Apogee Medical, Inc | 07/17/2008Terminated |
| Z-2392-2008 | Apogee Intermittent Catheter, 10 Fr 15", Catalog/Ref No. 1036, Sterile, Latex free. The…Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to… | Apogee Medical, Inc | 07/17/2008Terminated |
| Z-2391-2008 | Apogee Intermittent Catheter, 8 Fr 16", Catalog/Ref No. 1018, Sterile, Latex free. The…Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to… | Apogee Medical, Inc | 07/17/2008Terminated |
| Z-2390-2008 | Apogee Intermittent Catheter, 6 Fr 15", Catalog/Ref No. 1007, Sterile, Latex free. The…Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to… | Apogee Medical, Inc | 07/17/2008Terminated |