Product Code: GBM
FDA class 2
21 CFR 876.5130
Catheter, Urethral
Gastroenterology, Urology
The Catheter, Urethral (product code GBM) is a catheter designed for passage through the urethra into the bladder, used to drain urine or facilitate diagnostic or therapeutic procedures in urology. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification to demonstrate substantial equivalence to a predicate device. The device is regulated under 21 CFR 876.5130 in the Gastroenterology, Urology specialty (GU). It is eligible for review by an FDA-accredited third-party reviewer.
510(k)s
71
FEI Numbers
87
Registration Numbers
87
Unique Applicants
47
Years Active
49
Basic Information
- Product Code
- GBM
- Device Class
- FDA class 2
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 71 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K241734 | Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact | Mar 05, 2025 | Substantially Equivalent | Well Lead Medical Co., Ltd. |
| K213283 | GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter | Jun 22, 2022 | Substantially Equivalent | ConvaTec Limited |
| K211436 | Intermittent Catheter (Not Finalized) | Jan 27, 2022 | Substantially Equivalent | Hollister Incorporated |
| K200820 | SpeediCath Compact Set | Nov 13, 2020 | Substantially Equivalent | Coloplast |
| K192904 | SpeediCath Compact Set | Nov 02, 2020 | Substantially Equivalent | Coloplast |
| K200142 | SpeediCath Soft | Jul 30, 2020 | Substantially Equivalent | Coloplast |
| K200134 | Jimushi Sterile Urethral Catheter for single use | Jun 01, 2020 | Substantially Equivalent | Hangzhou Jimushi Meditech Co., Ltd. |
| K191512 | LotusCatheter (Lotus No Balloon Catheter) | May 21, 2020 | Unknown | Hakki Medical Technologies, Inc. |
| K192577 | Actreen Hi-Lite Intermittent Urinary Catheters | May 07, 2020 | Substantially Equivalent | B. Braun Medical Inc. |
| K193148 | VaPro Plus Pocket, VaPro Plus | Dec 13, 2019 | Substantially Equivalent | Hollister Incorporated |
| 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 | Nov 27, 2019 | Substantially Equivalent | Hangzhou Bever Medical Devices Co., Ltd. |
| K191633 | Infyna Chic | Jul 19, 2019 | Substantially Equivalent | Hollister Incorporated |
| K190620 | SpeediCath Flex Coude Pro | Jul 10, 2019 | Substantially Equivalent | Coloplast |
| K183335 | Medline Poly-Cath Red Polymer Urethral Catheter | Jun 12, 2019 | Substantially Equivalent | Medline Industries, Inc. |
| K183461 | Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter | May 08, 2019 | Unknown | Teleflex Medical, Inc |
| K182511 | SimplCath | Mar 20, 2019 | Substantially Equivalent | F&S Medical Solutions, LLC |
| K183253 | ValPro 2 Plus, VaPro 2 Plus Pocket | Dec 18, 2018 | Substantially Equivalent | Hollister Incorporated |
| K180801 | Actreen Hi-Lite Cath, Actreen Hi-Lite Set | Nov 05, 2018 | Substantially Equivalent | B. Braun Medical Inc. |
| K180258 | SpeediCath Standard | Oct 25, 2018 | Substantially Equivalent | Coloplast |
| K181206 | GentleCath Glide Intermittent Urinary Catheter | Aug 16, 2018 | Substantially Equivalent | ConvaTec Limited |
| K180824 | VaPro 2 Intermittent Catheter | Jun 22, 2018 | Substantially Equivalent | Hollister Incorporated |
| K180070 | SpeediCath Flex Coude Pro | Feb 02, 2018 | Substantially Equivalent | Coloplast |
| K172278 | Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent | Nov 22, 2017 | Substantially Equivalent | Cook Incorporated |
| K163179 | Onli Intermittent Catheter | Jan 26, 2017 | Substantially Equivalent | HOLLISTER INCORPORATED |
| K161672 | SpeediCath Flex Coude | Sep 29, 2016 | Substantially Equivalent | Coloplast Corp. |
| K160795 | United Urologics Intermittent Catheter | Jun 16, 2016 | Substantially Equivalent | ROBLING MEDICAL |
| K151772 | Actreen Mini Intermittent Urinary Catheters | Feb 09, 2016 | Substantially Equivalent | B. BRAUN MEDICAL INC. |
| K152268 | VAPRO PLUS POCKET Intermittent Catheter | Sep 09, 2015 | Substantially Equivalent | HOLLISTER INCORPORATED |
| K150935 | SpeediCath Compact Eve | Jul 02, 2015 | Substantially Equivalent | COLOPLAST A/S |
| K142767 | ThinkMed Intermittent Catheter with/without Hydrophilic Coating | Feb 03, 2015 | Substantially Equivalent | ThinkMed Medical Technology Co., Ltd. |
| K143182 | Speedicath Compact Male | Jan 20, 2015 | Substantially Equivalent | COLOPLAST A/S |
| K143594 | VaPro Pocket | Jan 09, 2015 | Substantially Equivalent | Hollister Incorporated |
| K141642 | VAPRO INTERMITTENT CATHETER | Aug 22, 2014 | Substantially Equivalent | HOLLISTER, INCORPORATED |
| K121457 | SPEEDICATH COMPACT SET (12 FR) | Oct 02, 2012 | Substantially Equivalent | COLOPLAST CORP. |
| K121458 | SPEEDICATH COMPACT SET (12/18 FR) | Oct 01, 2012 | Substantially Equivalent | COLOPLAST A/S |
| K111405 | BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER, | Feb 13, 2012 | Substantially Equivalent | HANGZHOU BEVER MEDICAL DEVICES CO., LTD. |
| K110862 | VAPRO PLUS INTERMITTENT CATHETER | Apr 26, 2011 | Substantially Equivalent | HOLLISTER, INCORPORATED |
| K101900 | HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH | Feb 07, 2011 | Substantially Equivalent | HAKKI MEDICAL TECHNOLOGIES, INC. |
| K090960 | VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184, | Aug 20, 2009 | Substantially Equivalent | HOLLISTER, INC. |
| K072808 | SPEEDICATH COMPACT | Nov 09, 2007 | Substantially Equivalent | COLOPLAST CORP. |
| K063795 | GUARDIANCATHETER-URINARY DRAINAGE CATHETER | Mar 05, 2007 | Substantially Equivalent | MARIAN MEDICAL, INC. |
| K060268 | PEDIATRIC URINARY CATHETER | Feb 24, 2006 | Substantially Equivalent | CLAY KENNARD |
| K050874 | ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER | May 05, 2005 | Substantially Equivalent | ASTRA TECH, INC. |
| K043241 | LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER | Dec 23, 2004 | Substantially Equivalent | ASTRA TECH, INC. |
| K031409 | URINARY CATHETERS | Jun 17, 2003 | Substantially Equivalent | PROMEDIC, INC. |
| K021938 | VITALCARE URETHRAL CATHETER | Apr 22, 2003 | Substantially Equivalent | VITALCARE, INC. |
| K023254 | SPEEDICATH | Jan 27, 2003 | Substantially Equivalent | COLOPLAST CORP. |
| K020714 | RUSCH FLONEIL; FLOCATH INTROGEL | Jul 01, 2002 | Substantially Equivalent | RUSCH INTL. |
| K012374 | MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER | Aug 23, 2001 | Substantially Equivalent | ASTRA TECH, INC. |
| K011552 | UROLOGICAL CATHETER | Jul 18, 2001 | Substantially Equivalent | APOGEE MEDICAL, INC. |
| K993651 | O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER | Dec 23, 1999 | Substantially Equivalent | SC HENNIG ENTERPRISES EUROPE SRL |
| K992137 | UROLOGICAL CATHETER | Sep 03, 1999 | Substantially Equivalent | APOGEE, INC. |
| K973120 | READYCATH CATHETER | Feb 25, 1998 | Substantially Equivalent | MEDICAL TECHNOLOGIES OF GEORGIA |
| K970704 | PERSONAL CATHETER | Mar 13, 1997 | Substantially Equivalent | ROCHESTER MEDICAL CORP. |
| K965067 | DILATION CATHETER, BALLOON | Jan 28, 1997 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K961361 | ASTA-CATH | Oct 31, 1996 | Substantially Equivalent | A+ PRODUCTS |
| K952924 | ADI CATHETER WITH VALVE | Aug 18, 1995 | Substantially Equivalent | ASIA DYNAMICS, INC. |
| K943851 | ALL SILICONE INTERMITTENT CATHETER | Jan 31, 1995 | Substantially Equivalent | ROCHESTER MEDICAL CORP. |
| K941672 | URI-CATH CATHETER | May 16, 1994 | Substantially Equivalent | GESCO INTL., INC. |
| K926369 | WALTHER CATHETERS, MALE, FEMALE | May 21, 1993 | Substantially Equivalent | THOMASVILLE MEDICAL ASSOC. |
| K914905 | ENTRAC(TM) URETHRAL MEASURING CATHETER | Mar 20, 1992 | Substantially Equivalent | AMERICAN MEDICAL SYSTEMS, INC. |
| K910876 | AUTOCATH(TM) SET | May 28, 1991 | Substantially Equivalent | COOK UROLOGICAL, INC. |
| K901441 | ALBERT MORTON UROLOGICAL CATHETER | Jun 22, 1990 | Substantially Equivalent | TRANSINTERNATIONAL MARKETING GROUP |
| K901336 | ASI HEMOSTASIS CATHETER | Jun 20, 1990 | Substantially Equivalent | ADVANCED SURGICAL INTERVENTION, INC. |
| K892442 | KENDALL CURITY URETHRAL CATHETERS | Jun 23, 1989 | Substantially Equivalent | THE KENDAL CO. |
| K881667 | KENDALL CURITY & KENGUARD RED RUBBER URETHRAL CATH | Aug 12, 1988 | Substantially Equivalent | THE KENDAL CO. |
| K871999 | MMG URO-SELF CATHETER | Aug 25, 1987 | Substantially Equivalent | MEDICAL MARKETING GROUP |
| K830840 | OPEN ENDED URETERAL CATHETER | Apr 06, 1983 | Substantially Equivalent | VAN-TEC, INC. |
| K760254 | TRAY, FOLEY CATHETER | Aug 23, 1976 | Substantially Equivalent | C.R. BARD, INC. |
| K760253 | TRAY, UNIVERSAL FOLY WO/DRAINAGE BAG | Aug 23, 1976 | Substantially Equivalent | C.R. BARD, INC. |
| K760093 | CATHETER, SILICONE FOLEY (BARDEX) | Aug 23, 1976 | Substantially Equivalent | C.R. BARD, INC. |
FEI Numbers
This FDA classification entry is associated with 87 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 87 registration numbers. Click on an entry to view related FDA registrations.