Panels › Gastroenterology, Urology › Product code GBM · Class 2
Catheter, Urethral
Regulation 876.5130
0510(k)s in 12 months (71 all time)
2recalls in 12 months (18 all time)
15recalls that name a 510(k)
Top companies in GBM
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 5, 2025 | K241734 | Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact Well Lead Medical Co., Ltd., CN | GBM |
| Jun 22, 2022 | K213283 | GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter Convatec Limited, GB | GBM |
| Jan 27, 2022 | K211436 | Intermittent Catheter (Not Finalized) Hollister Incorporated | GBM |
| Nov 13, 2020 | K200820 | SpeediCath Compact Set Coloplast | GBM |
| Nov 2, 2020 | K192904 | SpeediCath Compact Set Coloplast | GBM |
| Jul 30, 2020 | K200142 | SpeediCath Soft Coloplast | GBM |
| Jun 1, 2020 | K200134 | Jimushi Sterile Urethral Catheter for single use Hangzhou Jimushi Meditech Co., Ltd., CN | GBM |
| May 21, 2020 | K191512 | LotusCatheter (Lotus No Balloon Catheter) Hakki Medical Technologies, Inc. | GBM |
| May 7, 2020 | K192577 | Actreen Hi-Lite Intermittent Urinary Catheters B.Braun Medical, Inc. | GBM |
| Dec 13, 2019 | K193148 | VaPro Plus Pocket, VaPro Plus Hollister Incorporated | GBM |
| Nov 27, 2019 | K192468 | Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Ne Hangzhou Bever Medical Devices Co., Ltd., CN | GBM |
| Jul 19, 2019 | K191633 | Infyna Chic Hollister Incorporated | GBM |
| Jul 10, 2019 | K190620 | SpeediCath Flex Coude Pro Coloplast | GBM |
| Jun 12, 2019 | K183335 | Medline Poly-Cath Red Polymer Urethral Catheter Medline Industries, Inc. | GBM |
| May 8, 2019 | K183461 | Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter Teleflexmedical, Inc. | GBM |
| Mar 20, 2019 | K182511 | SimplCath F&S Medical Solutions, LLC | GBM |
| Dec 18, 2018 | K183253 | ValPro 2 Plus, VaPro 2 Plus Pocket Hollister Incorporated | GBM |
| Nov 5, 2018 | K180801 | Actreen Hi-Lite Cath, Actreen Hi-Lite Set B.Braun Medical, Inc. | GBM |
| Oct 25, 2018 | K180258 | SpeediCath Standard Coloplast | GBM |
| Aug 16, 2018 | K181206 | GentleCath Glide Intermittent Urinary Catheter Convatec Limited, GB | GBM |
| Jun 22, 2018 | K180824 | VaPro 2 Intermittent Catheter Hollister Incorporated | GBM |
| Feb 2, 2018 | K180070 | SpeediCath Flex Coude Pro Coloplast | GBM |
| Nov 22, 2017 | K172278 | Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent Cook Incorporated | GBM |
| Jan 26, 2017 | K163179 | Onli Intermittent Catheter Hollister Incorporated | GBM |
| Sep 29, 2016 | K161672 | SpeediCath Flex Coude Coloplast Corp. | GBM |
| Jun 16, 2016 | K160795 | United Urologics Intermittent Catheter Robling Medical | GBM |
| Feb 9, 2016 | K151772 | Actreen Mini Intermittent Urinary Catheters B.Braun Medical, Inc. | GBM |
| Sep 9, 2015 | K152268 | VAPRO PLUS POCKET Intermittent Catheter Hollister Incorporated | GBM |
| Jul 2, 2015 | K150935 | SpeediCath Compact Eve Coloplast A/S | GBM |
| Feb 3, 2015 | K142767 | ThinkMed Intermittent Catheter with/without Hydrophilic Coating Thinkmed Medical Technology Co., Ltd., CN | GBM |
| Jan 20, 2015 | K143182 | Speedicath Compact Male Coloplast A/S | GBM |
| Jan 9, 2015 | K143594 | VaPro Pocket Hollister Incorporated | GBM |
| Aug 22, 2014 | K141642 | VAPRO INTERMITTENT CATHETER Hollister Incorporated | GBM |
| Oct 2, 2012 | K121457 | SPEEDICATH COMPACT SET (12 FR) Coloplast Corp. | GBM |
| Oct 1, 2012 | K121458 | SPEEDICATH COMPACT SET (12/18 FR) Coloplast A/S | GBM |
| Feb 13, 2012 | K111405 | BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER, Hangzhou Bever Medical Devices Co., Ltd., CN | GBM |
| Apr 26, 2011 | K110862 | VAPRO PLUS INTERMITTENT CATHETER Hollister Incorporated | GBM |
| Feb 7, 2011 | K101900 | HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH Hakki Medical Technologies, Inc. | GBM |
| Aug 20, 2009 | K090960 | VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184, Hollister, Inc. | GBM |
| Nov 9, 2007 | K072808 | SPEEDICATH COMPACT Coloplast Corp. | GBM |
| Mar 5, 2007 | K063795 | GUARDIANCATHETER-URINARY DRAINAGE CATHETER Marian Medical, Inc. | GBM |
| Feb 24, 2006 | K060268 | PEDIATRIC URINARY CATHETER Clay Kennard | GBM |
| May 5, 2005 | K050874 | ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER Astra Tech, Inc. | GBM |
| Dec 23, 2004 | K043241 | LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER Astra Tech, Inc. | GBM |
| Jun 17, 2003 | K031409 | URINARY CATHETERS Promedic, Inc. | GBM |
| Apr 22, 2003 | K021938 | VITALCARE URETHRAL CATHETER Vitalcare, Inc. | GBM |
| Jan 27, 2003 | K023254 | SPEEDICATH Coloplast Corp. | GBM |
| Jul 1, 2002 | K020714 | RUSCH FLONEIL; FLOCATH INTROGEL Rusch Intl. | GBM |
| Aug 23, 2001 | K012374 | MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER Astra Tech, Inc. | GBM |
| Jul 18, 2001 | K011552 | UROLOGICAL CATHETER Apogee Medical, Inc. | GBM |
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