Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Catheter, Urethral

FDA product code GBM · 65 cleared devices

Class 2 Gastroenterology, Urology

Regulation: 21 CFR 876.5130
Review panel: GU
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-08-23 – 2025-03-05

GBM 2025-03-05

Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact

Applicant Well Lead Medical Co., Ltd.

K number K241734

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GBM 2022-06-22

GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter

Applicant Convatec Limited

K number K213283

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GBM 2022-01-27

Intermittent Catheter (Not Finalized)

Applicant Hollister Incorporated

K number K211436

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GBM 2020-11-13

SpeediCath Compact Set

Applicant Coloplast

K number K200820

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GBM 2020-11-02

SpeediCath Compact Set

Applicant Coloplast

K number K192904

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GBM 2020-07-30

SpeediCath Soft

Applicant Coloplast

K number K200142

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GBM 2020-06-01

Jimushi Sterile Urethral Catheter for single use

Applicant Hangzhou Jimushi Meditech Co., Ltd.

K number K200134

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GBM 2020-05-21

LotusCatheter (Lotus No Balloon Catheter)

Applicant Hakki Medical Technologies, Inc.

K number K191512

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GBM 2020-05-07

Actreen Hi-Lite Intermittent Urinary Catheters

Applicant B.Braun Medical, Inc.

K number K192577

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GBM 2019-12-13

VaPro Plus Pocket, VaPro Plus

Applicant Hollister Incorporated

K number K193148

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GBM 2019-11-27

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

Applicant Hangzhou Bever Medical Devices Co., Ltd.

K number K192468

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GBM 2019-07-19

Infyna Chic

Applicant Hollister Incorporated

K number K191633

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GBM 2019-07-10

SpeediCath Flex Coude Pro

Applicant Coloplast

K number K190620

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GBM 2019-06-12

Medline Poly-Cath Red Polymer Urethral Catheter

Applicant Medline Industries, Inc.

K number K183335

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GBM 2019-05-08

Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter

Applicant Teleflexmedical, Inc.

K number K183461

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GBM 2019-03-20

SimplCath

Applicant F&S Medical Solutions, LLC

K number K182511

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GBM 2018-12-18

ValPro 2 Plus, VaPro 2 Plus Pocket

Applicant Hollister Incorporated

K number K183253

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GBM 2018-11-05

Actreen Hi-Lite Cath, Actreen Hi-Lite Set

Applicant B.Braun Medical, Inc.

K number K180801

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GBM 2018-10-25

SpeediCath Standard

Applicant Coloplast

K number K180258

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GBM 2018-08-16

GentleCath Glide Intermittent Urinary Catheter

Applicant Convatec Limited

K number K181206

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GBM 2018-06-22

VaPro 2 Intermittent Catheter

Applicant Hollister Incorporated

K number K180824

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GBM 2018-02-02

SpeediCath Flex Coude Pro

Applicant Coloplast

K number K180070

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GBM 2017-11-22

Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent

Applicant Cook Incorporated

K number K172278

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GBM 2017-01-26

Onli Intermittent Catheter

Applicant Hollister Incorporated

K number K163179

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GBM 2016-09-29

SpeediCath Flex Coude

Applicant Coloplast Corp.

K number K161672

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GBM 2016-06-16

United Urologics Intermittent Catheter

Applicant Robling Medical

K number K160795

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GBM 2016-02-09

Actreen Mini Intermittent Urinary Catheters

Applicant B.Braun Medical, Inc.

K number K151772

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GBM 2012-10-02

SPEEDICATH COMPACT SET (12 FR)

Applicant Coloplast Corp.

K number K121457

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GBM 2012-10-01

SPEEDICATH COMPACT SET (12/18 FR)

Applicant Coloplast A/S

K number K121458

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GBM 2012-02-13

BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,

Applicant Hangzhou Bever Medical Devices Co., Ltd.

K number K111405

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GBM 2011-04-26

VAPRO PLUS INTERMITTENT CATHETER

Applicant Hollister Incorporated

K number K110862

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GBM 2011-02-07

HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH

Applicant Hakki Medical Technologies, Inc.

K number K101900

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GBM 2009-08-20

VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184,

Applicant Hollister, Inc.

K number K090960

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GBM 2007-11-09

SPEEDICATH COMPACT

Applicant Coloplast Corp.

K number K072808

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GBM 2007-03-05

GUARDIANCATHETER-URINARY DRAINAGE CATHETER

Applicant Marian Medical, Inc.

K number K063795

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GBM 2006-02-24

PEDIATRIC URINARY CATHETER

Applicant Clay Kennard

K number K060268

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GBM 2005-05-05

ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER

Applicant Astra Tech, Inc.

K number K050874

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GBM 2004-12-23

LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER

Applicant Astra Tech, Inc.

K number K043241

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GBM 2003-06-17

URINARY CATHETERS

Applicant Promedic, Inc.

K number K031409

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GBM 2003-04-22

VITALCARE URETHRAL CATHETER

Applicant Vitalcare, Inc.

K number K021938

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GBM 2003-01-27

SPEEDICATH

Applicant Coloplast Corp.

K number K023254

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GBM 2002-07-01

RUSCH FLONEIL; FLOCATH INTROGEL

Applicant Rusch Intl.

K number K020714

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GBM 2001-08-23

MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER

Applicant Astra Tech, Inc.

K number K012374

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GBM 2001-07-18

UROLOGICAL CATHETER

Applicant Apogee Medical, Inc.

K number K011552

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GBM 1999-12-23

O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER

Applicant Sc Hennig Enterprises Europe Srl

K number K993651

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GBM 1999-09-03

UROLOGICAL CATHETER

Applicant Apogee, Inc.

K number K992137

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GBM 1998-02-25

READYCATH CATHETER

Applicant Medical Technologies of Georgia

K number K973120

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GBM 1997-03-13

PERSONAL CATHETER

Applicant Rochester Medical Corp.

K number K970704

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GBM 1997-01-28

DILATION CATHETER, BALLOON

Applicant Boston Scientific Corp

K number K965067

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GBM 1996-10-31

ASTA-CATH

Applicant A+ Products

K number K961361

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GBM 1995-08-18

ADI CATHETER WITH VALVE

Applicant Asia Dynamics, Inc.

K number K952924

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GBM 1995-01-31

ALL SILICONE INTERMITTENT CATHETER

Applicant Rochester Medical Corp.

K number K943851

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GBM 1994-05-16

URI-CATH CATHETER

Applicant Gesco Intl., Inc.

K number K941672

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GBM 1993-05-21

WALTHER CATHETERS, MALE, FEMALE

Applicant Thomasville Medical Assoc.

K number K926369

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GBM 1992-03-20

ENTRAC(TM) URETHRAL MEASURING CATHETER

Applicant American Medical Systems, Inc.

K number K914905

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GBM 1991-05-28

AUTOCATH(TM) SET

Applicant Cook Urological, Inc.

K number K910876

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GBM 1990-06-22

ALBERT MORTON UROLOGICAL CATHETER

Applicant Transinternational Marketing Group

K number K901441

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GBM 1990-06-20

ASI HEMOSTASIS CATHETER

Applicant Advanced Surgical Intervention, Inc.

K number K901336

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GBM 1989-06-23

KENDALL CURITY URETHRAL CATHETERS

Applicant The Kendal Co.

K number K892442

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GBM 1988-08-12

KENDALL CURITY & KENGUARD RED RUBBER URETHRAL CATH

Applicant The Kendal Co.

K number K881667

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GBM 1987-08-25

MMG URO-SELF CATHETER

Applicant Medical Marketing Group

K number K871999

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GBM 1983-04-06

OPEN ENDED URETERAL CATHETER

Applicant Van-Tec, Inc.

K number K830840

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GBM 1976-08-23

TRAY, FOLEY CATHETER

Applicant C.R. Bard, Inc.

K number K760254

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GBM 1976-08-23

TRAY, UNIVERSAL FOLY WO/DRAINAGE BAG

Applicant C.R. Bard, Inc.

K number K760253

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GBM 1976-08-23

CATHETER, SILICONE FOLEY (BARDEX)

Applicant C.R. Bard, Inc.

K number K760093

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