FDA 510(k) Applications for Medical Device Product Code "GBM"
(Catheter, Urethral)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K961361 | A+ PRODUCTS | ASTA-CATH | 10/31/1996 |
| K011552 | APOGEE MEDICAL, INC. | UROLOGICAL CATHETER | 07/18/2001 |
| K992137 | APOGEE, INC. | UROLOGICAL CATHETER | 09/03/1999 |
| K050874 | ASTRA TECH, INC. | ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER | 05/05/2005 |
| K043241 | ASTRA TECH, INC. | LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER | 12/23/2004 |
| K012374 | ASTRA TECH, INC. | MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER | 08/23/2001 |
| K180801 | B. Braun Medical Inc. | Actreen Hi-Lite Cath, Actreen Hi-Lite Set | 11/05/2018 |
| K192577 | B. Braun Medical Inc. | Actreen Hi-Lite Intermittent Urinary Catheters | 05/07/2020 |
| K151772 | B. BRAUN MEDICAL INC. | Actreen Mini Intermittent Urinary Catheters | 02/09/2016 |
| K965067 | BOSTON SCIENTIFIC CORP. | DILATION CATHETER, BALLOON | 01/28/1997 |
| K060268 | CLAY KENNARD | PEDIATRIC URINARY CATHETER | 02/24/2006 |
| K192904 | Coloplast | SpeediCath Compact Set | 11/02/2020 |
| K200820 | Coloplast | SpeediCath Compact Set | 11/13/2020 |
| K180070 | Coloplast | SpeediCath Flex Coude Pro | 02/02/2018 |
| K190620 | Coloplast | SpeediCath Flex Coude Pro | 07/10/2019 |
| K200142 | Coloplast | SpeediCath Soft | 07/30/2020 |
| K180258 | Coloplast | SpeediCath Standard | 10/25/2018 |
| K150935 | COLOPLAST A/S | SpeediCath Compact Eve | 07/02/2015 |
| K143182 | COLOPLAST A/S | Speedicath Compact Male | 01/20/2015 |
| K121458 | COLOPLAST A/S | SPEEDICATH COMPACT SET (12/18 FR) | 10/01/2012 |
| K023254 | COLOPLAST CORP. | SPEEDICATH | 01/27/2003 |
| K072808 | COLOPLAST CORP. | SPEEDICATH COMPACT | 11/09/2007 |
| K121457 | COLOPLAST CORP. | SPEEDICATH COMPACT SET (12 FR) | 10/02/2012 |
| K161672 | Coloplast Corp. | SpeediCath Flex Coude | 09/29/2016 |
| K213283 | ConvaTec Limited | GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter | 06/22/2022 |
| K181206 | ConvaTec Limited | GentleCath Glide Intermittent Urinary Catheter | 08/16/2018 |
| K172278 | Cook Incorporated | Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent | 11/22/2017 |
| K182511 | F&S Medical Solutions, LLC | SimplCath | 03/20/2019 |
| K101900 | HAKKI MEDICAL TECHNOLOGIES, INC. | HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH | 02/07/2011 |
| K191512 | Hakki Medical Technologies, Inc. | LotusCatheter (Lotus No Balloon Catheter) | 05/21/2020 |
| K111405 | HANGZHOU BEVER MEDICAL DEVICES CO., LTD. | BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER, | 02/13/2012 |
| K192468 | Hangzhou Bever Medical Devices Co., Ltd. | Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, O | 11/27/2019 |
| K200134 | Hangzhou Jimushi Meditech Co., Ltd. | Jimushi Sterile Urethral Catheter for single use | 06/01/2020 |
| K191633 | Hollister Incorporated | Infyna Chic | 07/19/2019 |
| K211436 | Hollister Incorporated | Intermittent Catheter (Not Finalized) | 01/27/2022 |
| K163179 | HOLLISTER INCORPORATED | Onli Intermittent Catheter | 01/26/2017 |
| K183253 | Hollister Incorporated | ValPro 2 Plus, VaPro 2 Plus Pocket | 12/18/2018 |
| K180824 | Hollister Incorporated | VaPro 2 Intermittent Catheter | 06/22/2018 |
| K152268 | HOLLISTER INCORPORATED | VAPRO PLUS POCKET Intermittent Catheter | 09/09/2015 |
| K193148 | Hollister Incorporated | VaPro Plus Pocket, VaPro Plus | 12/13/2019 |
| K143594 | Hollister Incorporated | VaPro Pocket | 01/09/2015 |
| K090960 | HOLLISTER, INC. | VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184, | 08/20/2009 |
| K141642 | HOLLISTER, INCORPORATED | VAPRO INTERMITTENT CATHETER | 08/22/2014 |
| K110862 | HOLLISTER, INCORPORATED | VAPRO PLUS INTERMITTENT CATHETER | 04/26/2011 |
| K063795 | MARIAN MEDICAL, INC. | GUARDIANCATHETER-URINARY DRAINAGE CATHETER | 03/05/2007 |
| K973120 | MEDICAL TECHNOLOGIES OF GEORGIA | READYCATH CATHETER | 02/25/1998 |
| K183335 | Medline Industries, Inc. | Medline Poly-Cath Red Polymer Urethral Catheter | 06/12/2019 |
| K031409 | PROMEDIC, INC. | URINARY CATHETERS | 06/17/2003 |
| K160795 | ROBLING MEDICAL | United Urologics Intermittent Catheter | 06/16/2016 |
| K970704 | ROCHESTER MEDICAL CORP. | PERSONAL CATHETER | 03/13/1997 |
| K020714 | RUSCH INTL. | RUSCH FLONEIL; FLOCATH INTROGEL | 07/01/2002 |
| K993651 | SC HENNIG ENTERPRISES EUROPE SRL | O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER | 12/23/1999 |
| K183461 | Teleflex Medical, Inc | Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter | 05/08/2019 |
| K142767 | ThinkMed Medical Technology Co., Ltd. | ThinkMed Intermittent Catheter with/without Hydrophilic Coating | 02/03/2015 |
| K021938 | VITALCARE, INC. | VITALCARE URETHRAL CATHETER | 04/22/2003 |
| K241734 | Well Lead Medical Co., Ltd. | Wellead« Hydrophilic Intermittent Catheter Ready to Use; Wellead« Hydrophilic Intermittent Catheter Compact | 03/05/2025 |
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