Product code KOD— Gastroenterology, Urology

FDA has cleared 238 devices under product code KOD between 1976 and 2026, filed by 120 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20261 clearance
• 20222 clearances
• 20211 clearance
• 20191 clearance
• 20186 clearances
• 20171 clearance
• 20162 clearances
• 20141 clearance
• 20112 clearances
• 20101 clearance
• 20091 clearance
• 20082 clearances
• 20044 clearances
• 20031 clearance
• 20023 clearances

• C.R. Bard, Inc.10 clearances
• Abco Dealers, Inc.9 clearances
• Van-Tec, Inc.8 clearances
• The Kendal Co.7 clearances
• Cook Urological, Inc.6 clearances
• American Pharmaseal Div. Ahsc6 clearances
• Vance Products, Inc.5 clearances
• Medline Industries, Inc.5 clearances
• Inmed Corp.5 clearances
• Conphar, Inc.5 clearances

Death

5

Injury

1,129

Malfunction

7,019

Total

8,153

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• K251864 — Rubber Utility CatheterC.R. Bard, Inc.·2026-02-23
• K220036 — Wellead Ureteral CatheterWell Lead Medical Co., Ltd.·2022-12-16
• K220730 — allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.·2022-10-13
• K211032 — Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.·2021-11-19
• K181979 — Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.·2019-05-24
• K180354 — UroGen Ureteral CatheterUrogen Pharma, Ltd.·2018-10-30
• K181144 — Angled Tip Ureteral CatheterCook Incorporated·2018-06-28
• K180530 — Imager II Urology Torque CatheterBoston Scientific Corporation·2018-04-10
• K171810 — Cone Tip Ureteral Catheter, Rutner Universal Wedge CatheterCook Incorporated·2018-03-07
• K171600 — Renal Access Cobra Catheter, Kumpe Access CatheterCook Incorporated·2018-02-16
• K171662 — 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 CatheterCook Incorporated·2018-02-01
• K172924 — GentleCath Intermittent Urinary CatheterConvatec Limited·2017-11-21
• K161344 — GentleCath Glide Intermittent CatheterConvatec Limited·2016-09-20
• K160877 — United Urologics Closed System CatheterRobling Medical, Inc.·2016-05-20
• K140953 — GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETERConvatec, Ltd.·2014-08-01
• K110491 — BACKSTOP CATHETERPluromed, Inc.·2011-03-16
• K103349 — BACKSTOP CATHETERPluromed, Inc.·2011-01-07
• K102527 — IMAGER II UROLOGY TORQUE CATHETER (C1 TIP); IMAGER II UROLOGY TORQUE CATHETER (C2 TIPBoston Scientific Corporation·2010-11-05
• K090270 — BACKSTOP CATHETER, MODEL 60-0000-3100Pluromed, Inc.·2009-05-15
• K080878 — MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT)Medical Technologies of Georgia, Inc.·2008-07-17
• K080881 — CURE CATHETER CLOSED SYSTEMCure Medical, LLC·2008-06-11
• K040897 — DOVER ROB-NEL CATHETERTyco Healthcare·2004-07-20
• K041243 — DOVER RED RUBBER ROBINSON CATHETERTyco Healthcare·2004-07-07
• K033719 — BARD TIGERTAIL URETERAL CATHETERC.R. Bard, Inc.·2004-02-04
• K032710 — CLOSED SYSTEM INTERMITTENT CATHETERIZATION KITApogee Medical, Inc.·2004-01-09
• K033023 — INTERMITTENT URETHRAL CATHETERSRusch Intl.·2003-12-23
• K022135 — URETERAL ACCESS SHEATH SET (UASS)Boston Scientific Corp·2002-09-13
• K013483 — INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KITHollister, Inc.·2002-01-14
• K013345 — INCARE INTERMITTENT CATHETERHollister, Inc.·2002-01-07
• K011965 — IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1Boston Scientific Corp·2001-07-13
• K010339 — ENDOCARE PERCUTANEOUS ACCESS SETEndocare, Inc.·2001-03-07
• K002396 — ENDOCARE PERCUTANEOUS ACCESS SETEndocare, Inc.·2000-10-13
• K001583 — ISLAND BIOSURGICAL BNS KIT #3Island Biosurgical, LLC·2000-07-13
• K000723 — HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)Rochester Medical Corp.·2000-05-19
• K000070 — FLOCATHRusch Intl.·2000-02-18
• K965229 — IMAGER TORQUE CATHETERBoston Scientific Corp·1997-03-04
• K951260 — URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANTBiosearch Medical Products, Inc.·1995-09-27
• K945061 — NOPROFILE OLBERT CATHETER SYSTEMMeadox Surgimed, Inc.·1995-03-09
• K922527 — BARD URODYNAMIC CATHETERIZATION PROCEDURE TRAYC.R. Bard, Inc.·1994-04-14
• K933109 — 4SURE URO-LINK UROLOGICAL PROCEDURE TRAYSBoston Pacific Medical, Inc.·1994-03-28
• K915459 — FLOWMATE HAND PUMPPsi Medical Products, Inc.·1994-02-15
• K931195 — PERCUTANEOUS DRAINAGE LOOP CATHETER SETCook Urological, Inc.·1993-12-22
• K933400 — KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMPERATURE SENSORKendall Healthcare Products Co. Div.Of Tyco Health·1993-11-15
• K930608 — ONIK-COHEN ACCESS SETCook Urological, Inc.·1993-07-09
• K923906 — FOLEY INSERTION TRAYKit Pak, Inc.·1993-06-22
• K922051 — KIT PAK'S FLUSHING KITKit Pak, Inc.·1993-06-17
• K922431 — BARD LATEX URINARY CATHETERSC.R. Bard, Inc.·1993-03-25
• K923607 — RADIFOCUS GUIDE WIRE MTerumo Medical Corp.·1992-10-02
• K921054 — KENDALL MOD. PEDIATRIC ULTRAMER POLYURETHANE CATH.Kendall Healthcare Products Co. Div.Of Tyco Health·1992-09-23
• K921415 — IRRIGATION TUBING SETPsi Medical Products, Inc.·1992-09-04
• K921253 — INSTRUMENT IRRIGATION PUMPPsi Medical Products, Inc.·1992-08-06
• K914933 — HEART PACK IIIWestmark Hospital Supplies·1992-01-31
• K912851 — NAUDE URETHRAL STENTCook Urological, Inc.·1992-01-30
• K911242 — KENDALL PEDIATRIC ULTRAMER POLYURETHANE CATHETERKendall Healthcare Products Co. Div.Of Tyco Health·1991-04-25
• K900509 — NORTA SILICONE ELASTOMER COATED LATEX BALLOON CATHMedical Latex Corp.·1990-12-14
• K904734 — PHARMASEAL DISPOSABLE ABDOMINAL TROCARBaxter Healthcare Corp·1990-11-21
• K896729 — NELATON-, FEMALE - OR TIEMANN CATHETERUnoplast A/S·1990-11-05
• K896750 — LOFRIC(R), LOFRIC(R) CATH-KITAstra Meditec AB·1990-08-06
• K901738 — SELFCATHVitaid, Ltd.·1990-06-27
• K900229 — BARD CONFORMACATH FOLEY CATHETERC.R. Bard, Inc.·1990-04-17
• K900022 — BJ STAR ALL SILICONE FOLEY BALLOON CATHETERB.J. Star, Inc.·1990-03-15
• K896726 — 4 SURE EXTERNAL MALE CATHETERThe Boston & Pacific Co., Inc.·1990-02-26
• K896725 — 4 SURE UROLOGICAL CATHETERThe Boston & Pacific Co., Inc.·1990-02-16
• K896784 — DISPOSABLE URODYNAMIC CATHETER SETLife-Tech Intl., Inc.·1990-02-16
• K896053 — ALL SILICONE FOLEY CATHETERRochester Medical Corp.·1990-02-12
• K895548 — CONVEEN INTERMITTENT CATHETERSColoplast A/S·1990-02-09
• K896385 — URETERAL ACCESS SETApplied Urology, Inc.·1990-01-22
• K896208 — CYSTO PUMP DRAINAGE BAGWestmark, Sterile Packing Systems, Inc. (Sps)·1990-01-18
• K896211 — CYSTOSCOPY/IRRIGATION SETWestmark, Sterile Packing Systems, Inc. (Sps)·1990-01-18
• K896213 — Y-TYPE TUR/CONTINUOUS BLADDER IRRIGATION SETWestmark, Sterile Packing Systems, Inc. (Sps)·1990-01-18
• K890400 — MODIFIED URINARY CATHETER INTRODUCER (UCI)Go Medical Industries Pty. , Ltd.·1989-09-12
• K893390 — MODIFIED PRISTINE CULTURE CATHETERHml Medical, Inc.·1989-09-07
• K892436 — KENDALL CURITY IRRIGATION SYRINGEThe Kendal Co.·1989-07-14
• K892691 — CATHETERS, MALE, FEMALEZinnanti Surgical Instruments, Inc.·1989-06-23
• K885202 — 16 LONG CATHETER W/ADAPTER, 14 FR AND 12 FRCoeur Laboratories, Inc.·1989-01-31
• K883763 — ACME GUIDEWIRES FOR PERCUTANEOUS INSERTION OF CATHAcme-Monaco Corp.·1988-11-18
• K881781 — CATHETER STRAPBaxter Healthcare Corp·1988-08-02
• K881981 — ASSIST(TM) ASEPTIC SYRINGE IRRIGATION SYSTEMRyder Intl. Corp.·1988-08-02
• K881363 — SYRINGE PREFILLED WITH WATERI M, Inc.·1988-06-23
• K881646 — UROLOGICAL CATHETERCoeur Laboratories, Inc.·1988-06-16
• K880100 — COOK UROLOGICAL WIRE GUIDE W/HYDROMER COATINGCook Urological, Inc.·1988-03-15
• K875383 — LAKE CATHETER CARE KITS (MODIFICATION)Lake Medical Products, Inc.·1988-03-09
• K874112 — VAN-TEC DOUBLE OCCLUSION BALLOON CATHETERVan-Tec, Inc.·1988-02-11
• K874682 — MMG CATHETER PLUG W/DRAINAGE TUBE COVERMedical Marketing Group·1988-01-27
• K874525 — MODIFIED FOLEY CATHETER/TEMPERATURE SENSORMon-A-Therm, Inc.·1988-01-06
• K874293 — ACKRAD V/CUG VOIDING CYSTOURETHROGRAPHY SETAckrad Laboratories·1987-12-29
• K874312 — ACKRAD RETROGRADE URETHROGRAPHY SETAckrad Laboratories·1987-12-29
• K873448 — FOLEY CATHETER TEMPERATURE SENSORRespiratory Support Products, Inc.·1987-12-07
• K874517 — PHARMASEAL RUBBER URETHRAL CATHETERAmerican Pharmaseal Div. Ahsc·1987-12-03
• K873287 — IRRIGATION TRAY (W/120CC OF STERILE NORMAL SALINE)Todd Medical, Inc.·1987-11-13
• K873435 — LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SETLevel 1 Technologies, Inc.·1987-10-05
• K872750 — LAKE CATHETER CARE KITLake Medical Products, Inc.·1987-09-03
• K871429 — ANTIMICROBIAL FOLEY CATHETERAmerican Pharmaseal Div. Ahsc·1987-08-10
• K864592 — JUDD URETHAL CATHETER CONTAINERPhil Judd, Inc.·1987-06-24
• K870165 — FOLEY CATHETERAcorn Medical Products·1987-04-17
• K871297 — KADIR HI-TORQUE GUIDE WIREArgon Medical Corp.·1987-04-10
• K870977 — PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBEAmerican Pharmaseal Div. Ahsc·1987-04-01
• K870557 — VAN-TEC PUMPING SYSTEMVan-Tec, Inc.·1987-03-30
• K870694 — VAN-TEC OPEN ENDED CONE TIP URETERAL CATHETERVan-Tec, Inc.·1987-03-10
• K864736 — AKRO-SIL PLUSAkron Catheter, Inc.·1986-12-24