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, Urological

FDA product code KOD · 237 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 – 2026-02-23

KOD 2026-02-23

Rubber Utility Catheter

Applicant C.R. Bard, Inc.

K number K251864

View details →

KOD 2022-12-16

Wellead Ureteral Catheter

Applicant Well Lead Medical Co., Ltd.

K number K220036

View details →

KOD 2022-10-13

allFlex Ureteral Catheters, Krait Ureteral Catheters

Applicant Allwin Medical Devices, Inc.

K number K220730

View details →

KOD 2021-11-19

Urinary Catheter 12 Fr, Urinary Catheter 16 Fr

Applicant Urogen Pharma, Ltd.

K number K211032

View details →

KOD 2019-05-24

Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter

Applicant Teleflexmedical, Inc.

K number K181979

View details →

KOD 2018-10-30

UroGen Ureteral Catheter

Applicant Urogen Pharma, Ltd.

K number K180354

View details →

KOD 2018-06-28

Angled Tip Ureteral Catheter

Applicant Cook Incorporated

K number K181144

View details →

KOD 2018-04-10

Imager II Urology Torque Catheter

Applicant Boston Scientific Corporation

K number K180530

View details →

KOD 2018-03-07

Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter

Applicant Cook Incorporated

K number K171810

View details →

KOD 2018-02-16

Renal Access Cobra Catheter, Kumpe Access Catheter

Applicant Cook Incorporated

K number K171600

View details →

KOD 2018-02-01

Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter

Applicant Cook Incorporated

K number K171662

View details →

KOD 2017-11-21

GentleCath Intermittent Urinary Catheter

Applicant Convatec Limited

K number K172924

View details →

KOD 2016-09-20

GentleCath Glide Intermittent Catheter

Applicant Convatec Limited

K number K161344

View details →

KOD 2016-05-20

United Urologics Closed System Catheter

Applicant Robling Medical, Inc.

K number K160877

View details →

KOD 2011-03-16

BACKSTOP CATHETER

Applicant Pluromed, Inc.

K number K110491

View details →

KOD 2011-01-07

BACKSTOP CATHETER

Applicant Pluromed, Inc.

K number K103349

View details →

KOD 2010-11-05

IMAGER II UROLOGY TORQUE CATHETER (C1 TIP); IMAGER II UROLOGY TORQUE CATHETER (C2 TIP; IMAGER II UROLOGY TORQUE CATHETER

Applicant Boston Scientific Corporation

K number K102527

View details →

KOD 2009-05-15

BACKSTOP CATHETER, MODEL 60-0000-3100

Applicant Pluromed, Inc.

K number K090270

View details →

KOD 2008-07-17

MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT)

Applicant Medical Technologies of Georgia, Inc.

K number K080878

View details →

KOD 2008-06-11

CURE CATHETER CLOSED SYSTEM

Applicant Cure Medical, LLC

K number K080881

View details →

KOD 2004-07-20

DOVER ROB-NEL CATHETER

Applicant Tyco Healthcare

K number K040897

View details →

KOD 2004-07-07

DOVER RED RUBBER ROBINSON CATHETER

Applicant Tyco Healthcare

K number K041243

View details →

KOD 2004-02-04

BARD TIGERTAIL URETERAL CATHETER

Applicant C.R. Bard, Inc.

K number K033719

View details →

KOD 2004-01-09

CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT

Applicant Apogee Medical, Inc.

K number K032710

View details →

KOD 2003-12-23

INTERMITTENT URETHRAL CATHETERS

Applicant Rusch Intl.

K number K033023

View details →

KOD 2002-09-13

URETERAL ACCESS SHEATH SET (UASS)

Applicant Boston Scientific Corp

K number K022135

View details →

KOD 2002-01-14

INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT

Applicant Hollister, Inc.

K number K013483

View details →

KOD 2002-01-07

INCARE INTERMITTENT CATHETER

Applicant Hollister, Inc.

K number K013345

View details →

KOD 2001-07-13

IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1

Applicant Boston Scientific Corp

K number K011965

View details →

KOD 2001-03-07

ENDOCARE PERCUTANEOUS ACCESS SET

Applicant Endocare, Inc.

K number K010339

View details →

KOD 2000-10-13

ENDOCARE PERCUTANEOUS ACCESS SET

Applicant Endocare, Inc.

K number K002396

View details →

KOD 2000-07-13

ISLAND BIOSURGICAL BNS KIT #3

Applicant Island Biosurgical, LLC

K number K001583

View details →

KOD 2000-05-19

HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)

Applicant Rochester Medical Corp.

K number K000723

View details →

KOD 2000-02-18

FLOCATH

Applicant Rusch Intl.

K number K000070

View details →

KOD 1997-03-04

IMAGER TORQUE CATHETER

Applicant Boston Scientific Corp

K number K965229

View details →

KOD 1995-09-27

URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT

Applicant Biosearch Medical Products, Inc.

K number K951260

View details →

KOD 1995-03-09

NOPROFILE OLBERT CATHETER SYSTEM

Applicant Meadox Surgimed, Inc.

K number K945061

View details →

KOD 1994-04-14

BARD URODYNAMIC CATHETERIZATION PROCEDURE TRAY

Applicant C.R. Bard, Inc.

K number K922527

View details →

KOD 1994-03-28

4SURE URO-LINK UROLOGICAL PROCEDURE TRAYS

Applicant Boston Pacific Medical, Inc.

K number K933109

View details →

KOD 1994-02-15

FLOWMATE HAND PUMP

Applicant Psi Medical Products, Inc.

K number K915459

View details →

KOD 1993-12-22

PERCUTANEOUS DRAINAGE LOOP CATHETER SET

Applicant Cook Urological, Inc.

K number K931195

View details →

KOD 1993-11-15

KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMPERATURE SENSOR

Applicant Kendall Healthcare Products Co. Div.Of Tyco Health

K number K933400

View details →

KOD 1993-07-09

ONIK-COHEN ACCESS SET

Applicant Cook Urological, Inc.

K number K930608

View details →

KOD 1993-06-22

FOLEY INSERTION TRAY

Applicant Kit Pak, Inc.

K number K923906

View details →

KOD 1993-06-17

KIT PAK'S FLUSHING KIT

Applicant Kit Pak, Inc.

K number K922051

View details →

KOD 1993-03-25

BARD LATEX URINARY CATHETERS

Applicant C.R. Bard, Inc.

K number K922431

View details →

KOD 1992-10-02

RADIFOCUS GUIDE WIRE M

Applicant Terumo Medical Corp.

K number K923607

View details →

KOD 1992-09-23

KENDALL MOD. PEDIATRIC ULTRAMER POLYURETHANE CATH.

Applicant Kendall Healthcare Products Co. Div.Of Tyco Health

K number K921054

View details →

KOD 1992-09-04

IRRIGATION TUBING SET

Applicant Psi Medical Products, Inc.

K number K921415

View details →

KOD 1992-08-06

INSTRUMENT IRRIGATION PUMP

Applicant Psi Medical Products, Inc.

K number K921253

View details →

KOD 1992-01-31

HEART PACK III

Applicant Westmark Hospital Supplies

K number K914933

View details →

KOD 1992-01-30

NAUDE URETHRAL STENT

Applicant Cook Urological, Inc.

K number K912851

View details →

KOD 1991-04-25

KENDALL PEDIATRIC ULTRAMER POLYURETHANE CATHETER

Applicant Kendall Healthcare Products Co. Div.Of Tyco Health

K number K911242

View details →

KOD 1990-12-14

NORTA SILICONE ELASTOMER COATED LATEX BALLOON CATH

Applicant Medical Latex Corp.

K number K900509

View details →

KOD 1990-11-21

PHARMASEAL DISPOSABLE ABDOMINAL TROCAR

Applicant Baxter Healthcare Corp

K number K904734

View details →

KOD 1990-11-05

NELATON-, FEMALE - OR TIEMANN CATHETER

Applicant Unoplast A/S

K number K896729

View details →

KOD 1990-08-06

LOFRIC(R), LOFRIC(R) CATH-KIT

Applicant Astra Meditec AB

K number K896750

View details →

KOD 1990-06-27

SELFCATH

Applicant Vitaid, Ltd.

K number K901738

View details →

KOD 1990-04-17

BARD CONFORMACATH FOLEY CATHETER

Applicant C.R. Bard, Inc.

K number K900229

View details →

KOD 1990-03-15

BJ STAR ALL SILICONE FOLEY BALLOON CATHETER

Applicant B.J. Star, Inc.

K number K900022

View details →

KOD 1990-02-26

4 SURE EXTERNAL MALE CATHETER

Applicant The Boston & Pacific Co., Inc.

K number K896726

View details →

KOD 1990-02-16

DISPOSABLE URODYNAMIC CATHETER SET

Applicant Life-Tech Intl., Inc.

K number K896784

View details →

KOD 1990-02-16

4 SURE UROLOGICAL CATHETER

Applicant The Boston & Pacific Co., Inc.

K number K896725

View details →

KOD 1990-02-12

ALL SILICONE FOLEY CATHETER

Applicant Rochester Medical Corp.

K number K896053

View details →

KOD 1990-02-09

CONVEEN INTERMITTENT CATHETERS

Applicant Coloplast A/S

K number K895548

View details →

KOD 1990-01-22

URETERAL ACCESS SET

Applicant Applied Urology, Inc.

K number K896385

View details →

KOD 1990-01-18

Y-TYPE TUR/CONTINUOUS BLADDER IRRIGATION SET

Applicant Westmark, Sterile Packing Systems, Inc. (Sps)

K number K896213

View details →

KOD 1990-01-18

CYSTOSCOPY/IRRIGATION SET

Applicant Westmark, Sterile Packing Systems, Inc. (Sps)

K number K896211

View details →

KOD 1990-01-18

CYSTO PUMP DRAINAGE BAG

Applicant Westmark, Sterile Packing Systems, Inc. (Sps)

K number K896208

View details →

KOD 1989-09-12

MODIFIED URINARY CATHETER INTRODUCER (UCI)

Applicant Go Medical Industries Pty. , Ltd.

K number K890400

View details →

KOD 1989-09-07

MODIFIED PRISTINE CULTURE CATHETER

Applicant Hml Medical, Inc.

K number K893390

View details →

KOD 1989-07-14

KENDALL CURITY IRRIGATION SYRINGE

Applicant The Kendal Co.

K number K892436

View details →

KOD 1989-06-23

CATHETERS, MALE, FEMALE

Applicant Zinnanti Surgical Instruments, Inc.

K number K892691

View details →

KOD 1989-01-31

16 LONG CATHETER W/ADAPTER, 14 FR AND 12 FR

Applicant Coeur Laboratories, Inc.

K number K885202

View details →

KOD 1988-11-18

ACME GUIDEWIRES FOR PERCUTANEOUS INSERTION OF CATH

Applicant Acme-Monaco Corp.

K number K883763

View details →

KOD 1988-08-02

ASSIST(TM) ASEPTIC SYRINGE IRRIGATION SYSTEM

Applicant Ryder Intl. Corp.

K number K881981

View details →

KOD 1988-08-02

CATHETER STRAP

Applicant Baxter Healthcare Corp

K number K881781

View details →

KOD 1988-06-23

SYRINGE PREFILLED WITH WATER

Applicant I M, Inc.

K number K881363

View details →

KOD 1988-06-16

UROLOGICAL CATHETER

Applicant Coeur Laboratories, Inc.

K number K881646

View details →

KOD 1988-03-15

COOK UROLOGICAL WIRE GUIDE W/HYDROMER COATING

Applicant Cook Urological, Inc.

K number K880100

View details →

KOD 1988-03-09

LAKE CATHETER CARE KITS (MODIFICATION)

Applicant Lake Medical Products, Inc.

K number K875383

View details →

KOD 1988-02-11

VAN-TEC DOUBLE OCCLUSION BALLOON CATHETER

Applicant Van-Tec, Inc.

K number K874112

View details →

KOD 1988-01-27

MMG CATHETER PLUG W/DRAINAGE TUBE COVER

Applicant Medical Marketing Group

K number K874682

View details →

KOD 1988-01-06

MODIFIED FOLEY CATHETER/TEMPERATURE SENSOR

Applicant Mon-A-Therm, Inc.

K number K874525

View details →

KOD 1987-12-29

ACKRAD RETROGRADE URETHROGRAPHY SET

Applicant Ackrad Laboratories

K number K874312

View details →

KOD 1987-12-29

ACKRAD V/CUG VOIDING CYSTOURETHROGRAPHY SET

Applicant Ackrad Laboratories

K number K874293

View details →

KOD 1987-12-07

FOLEY CATHETER TEMPERATURE SENSOR

Applicant Respiratory Support Products, Inc.

K number K873448

View details →

KOD 1987-12-03

PHARMASEAL RUBBER URETHRAL CATHETER

Applicant American Pharmaseal Div. Ahsc

K number K874517

View details →

KOD 1987-11-13

IRRIGATION TRAY (W/120CC OF STERILE NORMAL SALINE)

Applicant Todd Medical, Inc.

K number K873287

View details →

KOD 1987-10-05

LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET

Applicant Level 1 Technologies, Inc.

K number K873435

View details →

KOD 1987-09-03

LAKE CATHETER CARE KIT

Applicant Lake Medical Products, Inc.

K number K872750

View details →

KOD 1987-08-10

ANTIMICROBIAL FOLEY CATHETER

Applicant American Pharmaseal Div. Ahsc

K number K871429

View details →

KOD 1987-06-24

JUDD URETHAL CATHETER CONTAINER

Applicant Phil Judd, Inc.

K number K864592

View details →

KOD 1987-04-17

FOLEY CATHETER

Applicant Acorn Medical Products

K number K870165

View details →

KOD 1987-04-10

KADIR HI-TORQUE GUIDE WIRE

Applicant Argon Medical Corp.

K number K871297

View details →

KOD 1987-04-01

PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE

Applicant American Pharmaseal Div. Ahsc

K number K870977

View details →

KOD 1987-03-30

VAN-TEC PUMPING SYSTEM

Applicant Van-Tec, Inc.

K number K870557

View details →

KOD 1987-03-10

VAN-TEC OPEN ENDED CONE TIP URETERAL CATHETER

Applicant Van-Tec, Inc.

K number K870694

View details →

KOD 1986-12-24

AKRO-SIL PLUS

Applicant Akron Catheter, Inc.

K number K864736

View details →

KOD 1986-11-19

CATHETER VALVES KV 100 & KV 100EH

Applicant Max Staubli , Ltd.

K number K861699

View details →

↑