FDA Product Code
FDA Product Code KOD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5130
510(k) Clearances — 238 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251864 | Rubber Utility Catheter | C.R. Bard, Inc. | 2026-02-23 | Traditional | PDF ↗ |
| K220036 | Wellead Ureteral Catheter | Well Lead Medical Co., Ltd. | 2022-12-16 | Traditional | PDF ↗ |
| K220730 | allFlex Ureteral Catheters, Krait Ureteral Catheters | Allwin Medical Devices, Inc. | 2022-10-13 | Traditional | PDF ↗ |
| K211032 | Urinary Catheter 12 Fr, Urinary Catheter 16 Fr | Urogen Pharma, Ltd. | 2021-11-19 | Traditional | PDF ↗ |
| K181979 | Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter | Teleflexmedical, Inc. | 2019-05-24 | Traditional | PDF ↗ |
| K180354 | UroGen Ureteral Catheter | Urogen Pharma, Ltd. | 2018-10-30 | Traditional | PDF ↗ |
| K181144 | Angled Tip Ureteral Catheter | Cook Incorporated | 2018-06-28 | Traditional | PDF ↗ |
| K180530 | Imager II Urology Torque Catheter | Boston Scientific Corporation | 2018-04-10 | Special | PDF ↗ |
| K171810 | Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter | Cook Incorporated | 2018-03-07 | Traditional | PDF ↗ |
| K171600 | Renal Access Cobra Catheter, Kumpe Access Catheter | Cook Incorporated | 2018-02-16 | Traditional | PDF ↗ |
| 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 Catheter | Cook Incorporated | 2018-02-01 | Traditional | PDF ↗ |
| K172924 | GentleCath Intermittent Urinary Catheter | Convatec Limited | 2017-11-21 | Traditional | PDF ↗ |
| K161344 | GentleCath Glide Intermittent Catheter | Convatec Limited | 2016-09-20 | Traditional | PDF ↗ |
| K160877 | United Urologics Closed System Catheter | Robling Medical, Inc. | 2016-05-20 | Traditional | PDF ↗ |
| K140953 | GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER | Convatec, Ltd. | 2014-08-01 | Traditional | PDF ↗ |
| K110491 | BACKSTOP CATHETER | Pluromed, Inc. | 2011-03-16 | Special | PDF ↗ |
| K103349 | BACKSTOP CATHETER | Pluromed, Inc. | 2011-01-07 | Abbreviated | PDF ↗ |
| K102527 | IMAGER II UROLOGY TORQUE CATHETER (C1 TIP); IMAGER II UROLOGY TORQUE CATHETER (C2 TIP; IMAGER II UROLOGY TORQUE CATHETER | Boston Scientific Corporation | 2010-11-05 | Traditional | PDF ↗ |
| K090270 | BACKSTOP CATHETER, MODEL 60-0000-3100 | Pluromed, Inc. | 2009-05-15 | Abbreviated | PDF ↗ |
| K080878 | MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT) | Medical Technologies of Georgia, Inc. | 2008-07-17 | Traditional | PDF ↗ |
| K080881 | CURE CATHETER CLOSED SYSTEM | Cure Medical, LLC | 2008-06-11 | Traditional | PDF ↗ |
| K040897 | DOVER ROB-NEL CATHETER | Tyco Healthcare | 2004-07-20 | Traditional | PDF ↗ |
| K041243 | DOVER RED RUBBER ROBINSON CATHETER | Tyco Healthcare | 2004-07-07 | Traditional | PDF ↗ |
| K033719 | BARD TIGERTAIL URETERAL CATHETER | C.R. Bard, Inc. | 2004-02-04 | Traditional | PDF ↗ |
| K032710 | CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT | Apogee Medical, Inc. | 2004-01-09 | Traditional | PDF ↗ |
| K033023 | INTERMITTENT URETHRAL CATHETERS | Rusch Intl. | 2003-12-23 | Traditional | PDF ↗ |
| K022135 | URETERAL ACCESS SHEATH SET (UASS) | Boston Scientific Corp | 2002-09-13 | Abbreviated | PDF ↗ |
| K013483 | INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT | Hollister, Inc. | 2002-01-14 | Traditional | PDF ↗ |
| K013345 | INCARE INTERMITTENT CATHETER | Hollister, Inc. | 2002-01-07 | Traditional | PDF ↗ |
| K011965 | IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1 | Boston Scientific Corp | 2001-07-13 | Special | PDF ↗ |
| K010339 | ENDOCARE PERCUTANEOUS ACCESS SET | Endocare, Inc. | 2001-03-07 | Special | PDF ↗ |
| K002396 | ENDOCARE PERCUTANEOUS ACCESS SET | Endocare, Inc. | 2000-10-13 | Traditional | PDF ↗ |
| K001583 | ISLAND BIOSURGICAL BNS KIT #3 | Island Biosurgical, LLC | 2000-07-13 | Traditional | PDF ↗ |
| K000723 | HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC) | Rochester Medical Corp. | 2000-05-19 | Traditional | PDF ↗ |
| K000070 | FLOCATH | Rusch Intl. | 2000-02-18 | Traditional | PDF ↗ |
| K965229 | IMAGER TORQUE CATHETER | Boston Scientific Corp | 1997-03-04 | Traditional | PDF ↗ |
| K951260 | URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT | Biosearch Medical Products, Inc. | 1995-09-27 | Traditional | PDF ↗ |
| K945061 | NOPROFILE OLBERT CATHETER SYSTEM | Meadox Surgimed, Inc. | 1995-03-09 | Traditional | PDF ↗ |
| K922527 | BARD URODYNAMIC CATHETERIZATION PROCEDURE TRAY | C.R. Bard, Inc. | 1994-04-14 | Traditional | PDF ↗ |
| K933109 | 4SURE URO-LINK UROLOGICAL PROCEDURE TRAYS | Boston Pacific Medical, Inc. | 1994-03-28 | Traditional | PDF ↗ |
| K915459 | FLOWMATE HAND PUMP | Psi Medical Products, Inc. | 1994-02-15 | Traditional | PDF ↗ |
| K931195 | PERCUTANEOUS DRAINAGE LOOP CATHETER SET | Cook Urological, Inc. | 1993-12-22 | Traditional | PDF ↗ |
| K933400 | KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMPERATURE SENSOR | Kendall Healthcare Products Co. Div.Of Tyco Health | 1993-11-15 | Traditional | PDF ↗ |
| K930608 | ONIK-COHEN ACCESS SET | Cook Urological, Inc. | 1993-07-09 | Traditional | PDF ↗ |
| K923906 | FOLEY INSERTION TRAY | Kit Pak, Inc. | 1993-06-22 | Traditional | PDF ↗ |
| K922051 | KIT PAK'S FLUSHING KIT | Kit Pak, Inc. | 1993-06-17 | Traditional | PDF ↗ |
| K922431 | BARD LATEX URINARY CATHETERS | C.R. Bard, Inc. | 1993-03-25 | Traditional | PDF ↗ |
| K923607 | RADIFOCUS GUIDE WIRE M | Terumo Medical Corp. | 1992-10-02 | Traditional | PDF ↗ |
| K921054 | KENDALL MOD. PEDIATRIC ULTRAMER POLYURETHANE CATH. | Kendall Healthcare Products Co. Div.Of Tyco Health | 1992-09-23 | Traditional | PDF ↗ |
| K921415 | IRRIGATION TUBING SET | Psi Medical Products, Inc. | 1992-09-04 | Traditional | PDF ↗ |
| K921253 | INSTRUMENT IRRIGATION PUMP | Psi Medical Products, Inc. | 1992-08-06 | Traditional | PDF ↗ |
| K914933 | HEART PACK III | Westmark Hospital Supplies | 1992-01-31 | Traditional | PDF ↗ |
| K912851 | NAUDE URETHRAL STENT | Cook Urological, Inc. | 1992-01-30 | Traditional | PDF ↗ |
| K911242 | KENDALL PEDIATRIC ULTRAMER POLYURETHANE CATHETER | Kendall Healthcare Products Co. Div.Of Tyco Health | 1991-04-25 | Traditional | PDF ↗ |
| K900509 | NORTA SILICONE ELASTOMER COATED LATEX BALLOON CATH | Medical Latex Corp. | 1990-12-14 | Traditional | PDF ↗ |
| K904734 | PHARMASEAL DISPOSABLE ABDOMINAL TROCAR | Baxter Healthcare Corp | 1990-11-21 | Traditional | PDF ↗ |
| K896729 | NELATON-, FEMALE - OR TIEMANN CATHETER | Unoplast A/S | 1990-11-05 | Traditional | PDF ↗ |
| K896750 | LOFRIC(R), LOFRIC(R) CATH-KIT | Astra Meditec AB | 1990-08-06 | Traditional | PDF ↗ |
| K901738 | SELFCATH | Vitaid, Ltd. | 1990-06-27 | Traditional | PDF ↗ |
| K900229 | BARD CONFORMACATH FOLEY CATHETER | C.R. Bard, Inc. | 1990-04-17 | Traditional | PDF ↗ |
| K900022 | BJ STAR ALL SILICONE FOLEY BALLOON CATHETER | B.J. Star, Inc. | 1990-03-15 | Traditional | PDF ↗ |
| K896726 | 4 SURE EXTERNAL MALE CATHETER | The Boston & Pacific Co., Inc. | 1990-02-26 | Traditional | PDF ↗ |
| K896784 | DISPOSABLE URODYNAMIC CATHETER SET | Life-Tech Intl., Inc. | 1990-02-16 | Traditional | PDF ↗ |
| K896725 | 4 SURE UROLOGICAL CATHETER | The Boston & Pacific Co., Inc. | 1990-02-16 | Traditional | PDF ↗ |
| K896053 | ALL SILICONE FOLEY CATHETER | Rochester Medical Corp. | 1990-02-12 | Traditional | PDF ↗ |
| K895548 | CONVEEN INTERMITTENT CATHETERS | Coloplast A/S | 1990-02-09 | Traditional | PDF ↗ |
| K896385 | URETERAL ACCESS SET | Applied Urology, Inc. | 1990-01-22 | Traditional | PDF ↗ |
| K896208 | CYSTO PUMP DRAINAGE BAG | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-01-18 | Traditional | PDF ↗ |
| K896213 | Y-TYPE TUR/CONTINUOUS BLADDER IRRIGATION SET | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-01-18 | Traditional | PDF ↗ |
| K896211 | CYSTOSCOPY/IRRIGATION SET | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-01-18 | Traditional | PDF ↗ |
| K890400 | MODIFIED URINARY CATHETER INTRODUCER (UCI) | Go Medical Industries Pty. , Ltd. | 1989-09-12 | Traditional | PDF ↗ |
| K893390 | MODIFIED PRISTINE CULTURE CATHETER | Hml Medical, Inc. | 1989-09-07 | Traditional | PDF ↗ |
| K892436 | KENDALL CURITY IRRIGATION SYRINGE | The Kendal Co. | 1989-07-14 | Traditional | PDF ↗ |
| K892691 | CATHETERS, MALE, FEMALE | Zinnanti Surgical Instruments, Inc. | 1989-06-23 | Traditional | PDF ↗ |
| K885202 | 16 LONG CATHETER W/ADAPTER, 14 FR AND 12 FR | Coeur Laboratories, Inc. | 1989-01-31 | Traditional | PDF ↗ |
| K883763 | ACME GUIDEWIRES FOR PERCUTANEOUS INSERTION OF CATH | Acme-Monaco Corp. | 1988-11-18 | Traditional | PDF ↗ |
| K881981 | ASSIST(TM) ASEPTIC SYRINGE IRRIGATION SYSTEM | Ryder Intl. Corp. | 1988-08-02 | Traditional | PDF ↗ |
| K881781 | CATHETER STRAP | Baxter Healthcare Corp | 1988-08-02 | Traditional | PDF ↗ |
| K881363 | SYRINGE PREFILLED WITH WATER | I M, Inc. | 1988-06-23 | Traditional | PDF ↗ |
| K881646 | UROLOGICAL CATHETER | Coeur Laboratories, Inc. | 1988-06-16 | Traditional | PDF ↗ |
| K880100 | COOK UROLOGICAL WIRE GUIDE W/HYDROMER COATING | Cook Urological, Inc. | 1988-03-15 | Traditional | PDF ↗ |
| K875383 | LAKE CATHETER CARE KITS (MODIFICATION) | Lake Medical Products, Inc. | 1988-03-09 | Traditional | PDF ↗ |
| K874112 | VAN-TEC DOUBLE OCCLUSION BALLOON CATHETER | Van-Tec, Inc. | 1988-02-11 | Traditional | PDF ↗ |
| K874682 | MMG CATHETER PLUG W/DRAINAGE TUBE COVER | Medical Marketing Group | 1988-01-27 | Traditional | PDF ↗ |
| K874525 | MODIFIED FOLEY CATHETER/TEMPERATURE SENSOR | Mon-A-Therm, Inc. | 1988-01-06 | Traditional | PDF ↗ |
| K874293 | ACKRAD V/CUG VOIDING CYSTOURETHROGRAPHY SET | Ackrad Laboratories | 1987-12-29 | Traditional | PDF ↗ |
| K874312 | ACKRAD RETROGRADE URETHROGRAPHY SET | Ackrad Laboratories | 1987-12-29 | Traditional | PDF ↗ |
| K873448 | FOLEY CATHETER TEMPERATURE SENSOR | Respiratory Support Products, Inc. | 1987-12-07 | Traditional | PDF ↗ |
| K874517 | PHARMASEAL RUBBER URETHRAL CATHETER | American Pharmaseal Div. Ahsc | 1987-12-03 | Traditional | PDF ↗ |
| K873287 | IRRIGATION TRAY (W/120CC OF STERILE NORMAL SALINE) | Todd Medical, Inc. | 1987-11-13 | Traditional | PDF ↗ |
| K873435 | LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET | Level 1 Technologies, Inc. | 1987-10-05 | Traditional | PDF ↗ |
| K872750 | LAKE CATHETER CARE KIT | Lake Medical Products, Inc. | 1987-09-03 | Traditional | PDF ↗ |
| K871429 | ANTIMICROBIAL FOLEY CATHETER | American Pharmaseal Div. Ahsc | 1987-08-10 | Traditional | PDF ↗ |
| K864592 | JUDD URETHAL CATHETER CONTAINER | Phil Judd, Inc. | 1987-06-24 | Traditional | PDF ↗ |
| K870165 | FOLEY CATHETER | Acorn Medical Products | 1987-04-17 | Traditional | PDF ↗ |
| K871297 | KADIR HI-TORQUE GUIDE WIRE | Argon Medical Corp. | 1987-04-10 | Traditional | PDF ↗ |
| K870977 | PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE | American Pharmaseal Div. Ahsc | 1987-04-01 | Traditional | PDF ↗ |
| K870557 | VAN-TEC PUMPING SYSTEM | Van-Tec, Inc. | 1987-03-30 | Traditional | PDF ↗ |
| K870694 | VAN-TEC OPEN ENDED CONE TIP URETERAL CATHETER | Van-Tec, Inc. | 1987-03-10 | Traditional | PDF ↗ |
| K864736 | AKRO-SIL PLUS | Akron Catheter, Inc. | 1986-12-24 | Traditional | PDF ↗ |
Product code KOD · Class II · Gastroenterology, Urology. Data: openFDA.