FDA Product Code
FDA Product Code GBM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5130
510(k) Clearances — 71 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K241734 | Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact | Well Lead Medical Co., Ltd. | 2025-03-05 | Traditional | PDF ↗ |
| K213283 | GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter | Convatec Limited | 2022-06-22 | Traditional | PDF ↗ |
| K211436 | Intermittent Catheter (Not Finalized) | Hollister Incorporated | 2022-01-27 | Traditional | PDF ↗ |
| K200820 | SpeediCath Compact Set | Coloplast | 2020-11-13 | Traditional | PDF ↗ |
| K192904 | SpeediCath Compact Set | Coloplast | 2020-11-02 | Traditional | PDF ↗ |
| K200142 | SpeediCath Soft | Coloplast | 2020-07-30 | Traditional | PDF ↗ |
| K200134 | Jimushi Sterile Urethral Catheter for single use | Hangzhou Jimushi Meditech Co., Ltd. | 2020-06-01 | Traditional | PDF ↗ |
| K191512 | LotusCatheter (Lotus No Balloon Catheter) | Hakki Medical Technologies, Inc. | 2020-05-21 | Traditional | PDF ↗ |
| K192577 | Actreen Hi-Lite Intermittent Urinary Catheters | B.Braun Medical, Inc. | 2020-05-07 | Special | PDF ↗ |
| K193148 | VaPro Plus Pocket, VaPro Plus | Hollister Incorporated | 2019-12-13 | Special | PDF ↗ |
| K192468 | 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, Olive-Tip Tiemann Ready-to-Use Hydrophilic Catheter | Hangzhou Bever Medical Devices Co., Ltd. | 2019-11-27 | Traditional | PDF ↗ |
| K191633 | Infyna Chic | Hollister Incorporated | 2019-07-19 | Special | PDF ↗ |
| K190620 | SpeediCath Flex Coude Pro | Coloplast | 2019-07-10 | Traditional | PDF ↗ |
| K183335 | Medline Poly-Cath Red Polymer Urethral Catheter | Medline Industries, Inc. | 2019-06-12 | Traditional | PDF ↗ |
| K183461 | Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter | Teleflexmedical, Inc. | 2019-05-08 | Traditional | PDF ↗ |
| K182511 | SimplCath | F&S Medical Solutions, LLC | 2019-03-20 | Traditional | PDF ↗ |
| K183253 | ValPro 2 Plus, VaPro 2 Plus Pocket | Hollister Incorporated | 2018-12-18 | Special | PDF ↗ |
| K180801 | Actreen Hi-Lite Cath, Actreen Hi-Lite Set | B.Braun Medical, Inc. | 2018-11-05 | Traditional | PDF ↗ |
| K180258 | SpeediCath Standard | Coloplast | 2018-10-25 | Traditional | PDF ↗ |
| K181206 | GentleCath Glide Intermittent Urinary Catheter | Convatec Limited | 2018-08-16 | Traditional | PDF ↗ |
| K180824 | VaPro 2 Intermittent Catheter | Hollister Incorporated | 2018-06-22 | Special | PDF ↗ |
| K180070 | SpeediCath Flex Coude Pro | Coloplast | 2018-02-02 | Special | PDF ↗ |
| K172278 | Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent | Cook Incorporated | 2017-11-22 | Traditional | PDF ↗ |
| K163179 | Onli Intermittent Catheter | Hollister Incorporated | 2017-01-26 | Special | PDF ↗ |
| K161672 | SpeediCath Flex Coude | Coloplast Corp. | 2016-09-29 | Traditional | PDF ↗ |
| K160795 | United Urologics Intermittent Catheter | Robling Medical | 2016-06-16 | Traditional | PDF ↗ |
| K151772 | Actreen Mini Intermittent Urinary Catheters | B.Braun Medical, Inc. | 2016-02-09 | Traditional | PDF ↗ |
| K152268 | VAPRO PLUS POCKET Intermittent Catheter | Hollister Incorporated | 2015-09-09 | Special | PDF ↗ |
| K150935 | SpeediCath Compact Eve | Coloplast A/S | 2015-07-02 | Traditional | PDF ↗ |
| K142767 | ThinkMed Intermittent Catheter with/without Hydrophilic Coating | Thinkmed Medical Technology Co., Ltd. | 2015-02-03 | Traditional | PDF ↗ |
| K143182 | Speedicath Compact Male | Coloplast A/S | 2015-01-20 | Traditional | PDF ↗ |
| K143594 | VaPro Pocket | Hollister Incorporated | 2015-01-09 | Special | PDF ↗ |
| K141642 | VAPRO INTERMITTENT CATHETER | Hollister Incorporated | 2014-08-22 | Special | PDF ↗ |
| K121457 | SPEEDICATH COMPACT SET (12 FR) | Coloplast Corp. | 2012-10-02 | Traditional | PDF ↗ |
| K121458 | SPEEDICATH COMPACT SET (12/18 FR) | Coloplast A/S | 2012-10-01 | Traditional | PDF ↗ |
| K111405 | BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER, | Hangzhou Bever Medical Devices Co., Ltd. | 2012-02-13 | Traditional | PDF ↗ |
| K110862 | VAPRO PLUS INTERMITTENT CATHETER | Hollister Incorporated | 2011-04-26 | Special | PDF ↗ |
| K101900 | HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH | Hakki Medical Technologies, Inc. | 2011-02-07 | Traditional | PDF ↗ |
| K090960 | VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184, | Hollister, Inc. | 2009-08-20 | Traditional | PDF ↗ |
| K072808 | SPEEDICATH COMPACT | Coloplast Corp. | 2007-11-09 | Traditional | PDF ↗ |
| K063795 | GUARDIANCATHETER-URINARY DRAINAGE CATHETER | Marian Medical, Inc. | 2007-03-05 | Traditional | PDF ↗ |
| K060268 | PEDIATRIC URINARY CATHETER | Clay Kennard | 2006-02-24 | Traditional | PDF ↗ |
| K050874 | ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER | Astra Tech, Inc. | 2005-05-05 | Special | PDF ↗ |
| K043241 | LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER | Astra Tech, Inc. | 2004-12-23 | Special | PDF ↗ |
| K031409 | URINARY CATHETERS | Promedic, Inc. | 2003-06-17 | Traditional | PDF ↗ |
| K021938 | VITALCARE URETHRAL CATHETER | Vitalcare, Inc. | 2003-04-22 | Traditional | PDF ↗ |
| K023254 | SPEEDICATH | Coloplast Corp. | 2003-01-27 | Traditional | PDF ↗ |
| K020714 | RUSCH FLONEIL; FLOCATH INTROGEL | Rusch Intl. | 2002-07-01 | Traditional | PDF ↗ |
| K012374 | MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER | Astra Tech, Inc. | 2001-08-23 | Special | PDF ↗ |
| K011552 | UROLOGICAL CATHETER | Apogee Medical, Inc. | 2001-07-18 | Traditional | PDF ↗ |
| K993651 | O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER | Sc Hennig Enterprises Europe Srl | 1999-12-23 | Traditional | PDF ↗ |
| K992137 | UROLOGICAL CATHETER | Apogee, Inc. | 1999-09-03 | Traditional | PDF ↗ |
| K973120 | READYCATH CATHETER | Medical Technologies of Georgia | 1998-02-25 | Traditional | PDF ↗ |
| K970704 | PERSONAL CATHETER | Rochester Medical Corp. | 1997-03-13 | Traditional | PDF ↗ |
| K965067 | DILATION CATHETER, BALLOON | Boston Scientific Corp | 1997-01-28 | Traditional | PDF ↗ |
| K961361 | ASTA-CATH | A+ Products | 1996-10-31 | Traditional | PDF ↗ |
| K952924 | ADI CATHETER WITH VALVE | Asia Dynamics, Inc. | 1995-08-18 | Traditional | PDF ↗ |
| K943851 | ALL SILICONE INTERMITTENT CATHETER | Rochester Medical Corp. | 1995-01-31 | Traditional | PDF ↗ |
| K941672 | URI-CATH CATHETER | Gesco Intl., Inc. | 1994-05-16 | Traditional | PDF ↗ |
| K926369 | WALTHER CATHETERS, MALE, FEMALE | Thomasville Medical Assoc. | 1993-05-21 | Traditional | PDF ↗ |
| K914905 | ENTRAC(TM) URETHRAL MEASURING CATHETER | American Medical Systems, Inc. | 1992-03-20 | Traditional | PDF ↗ |
| K910876 | AUTOCATH(TM) SET | Cook Urological, Inc. | 1991-05-28 | Traditional | PDF ↗ |
| K901441 | ALBERT MORTON UROLOGICAL CATHETER | Transinternational Marketing Group | 1990-06-22 | Traditional | PDF ↗ |
| K901336 | ASI HEMOSTASIS CATHETER | Advanced Surgical Intervention, Inc. | 1990-06-20 | Traditional | PDF ↗ |
| K892442 | KENDALL CURITY URETHRAL CATHETERS | The Kendal Co. | 1989-06-23 | Traditional | PDF ↗ |
| K881667 | KENDALL CURITY & KENGUARD RED RUBBER URETHRAL CATH | The Kendal Co. | 1988-08-12 | Traditional | PDF ↗ |
| K871999 | MMG URO-SELF CATHETER | Medical Marketing Group | 1987-08-25 | Traditional | PDF ↗ |
| K830840 | OPEN ENDED URETERAL CATHETER | Van-Tec, Inc. | 1983-04-06 | Traditional | PDF ↗ |
| K760253 | TRAY, UNIVERSAL FOLY WO/DRAINAGE BAG | C.R. Bard, Inc. | 1976-08-23 | Traditional | PDF ↗ |
| K760254 | TRAY, FOLEY CATHETER | C.R. Bard, Inc. | 1976-08-23 | Traditional | PDF ↗ |
| K760093 | CATHETER, SILICONE FOLEY (BARDEX) | C.R. Bard, Inc. | 1976-08-23 | Traditional | PDF ↗ |
Product code GBM · Class II · Gastroenterology, Urology. Data: openFDA.