KOD · Catheter, Urological
Gastroenterology, Urology · 21 CFR 876.5130 · Class 2
Overview
| Product Code | KOD |
|---|---|
| Device Name | Catheter, Urological |
| Regulation | 21 CFR 876.5130 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| 3rd-Party Reviewable | Yes |
Identification
A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).
Classification Rationale
(1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Cleared Devices (238)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251864 | Rubber Utility Catheter | C.R. Bard, Inc. | Feb 23, 2026 | SESE |
| K220036 | Wellead Ureteral Catheter | Well Lead Medical Co., Ltd. | Dec 16, 2022 | SESE |
| K220730 | allFlex Ureteral Catheters, Krait Ureteral Catheters | Allwin Medical Devices, Inc. | Oct 13, 2022 | SESE |
| K211032 | Urinary Catheter 12 Fr, Urinary Catheter 16 Fr | Urogen Pharma, Ltd. | Nov 19, 2021 | SESE |
| K181979 | Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter | Teleflexmedical, Inc. | May 24, 2019 | SESE |
| K180354 | UroGen Ureteral Catheter | Urogen Pharma, Ltd. | Oct 30, 2018 | SESE |
| K181144 | Angled Tip Ureteral Catheter | Cook Incorporated | Jun 28, 2018 | SESE |
| K180530 | Imager II Urology Torque Catheter | Boston Scientific Corporation | Apr 10, 2018 | SESE |
| K171810 | Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter | Cook Incorporated | Mar 7, 2018 | SESE |
| K171600 | Renal Access Cobra Catheter, Kumpe Access Catheter | Cook Incorporated | Feb 16, 2018 | SESE |
| 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 | Feb 1, 2018 | SESE |
| K172924 | GentleCath Intermittent Urinary Catheter | Convatec Limited | Nov 21, 2017 | SESE |
| K161344 | GentleCath Glide Intermittent Catheter | Convatec Limited | Sep 20, 2016 | SESE |
| K160877 | United Urologics Closed System Catheter | Robling Medical, Inc. | May 20, 2016 | SESE |
| K140953 | GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER | Convatec, Ltd. | Aug 1, 2014 | SESE |
| K110491 | BACKSTOP CATHETER | Pluromed, Inc. | Mar 16, 2011 | SESE |
| K103349 | BACKSTOP CATHETER | Pluromed, Inc. | Jan 7, 2011 | SESE |
| K102527 | IMAGER II UROLOGY TORQUE CATHETER (C1 TIP); IMAGER II UROLOGY TORQUE CATHETER (C2 TIP; IMAGER II UROLOGY TORQUE CATHETER | Boston Scientific Corporation | Nov 5, 2010 | SESE |
| K090270 | BACKSTOP CATHETER, MODEL 60-0000-3100 | Pluromed, Inc. | May 15, 2009 | SESE |
| K080878 | MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT) | Medical Technologies of Georgia, Inc. | Jul 17, 2008 | SESE |
| K080881 | CURE CATHETER CLOSED SYSTEM | Cure Medical, LLC | Jun 11, 2008 | SESE |
| K040897 | DOVER ROB-NEL CATHETER | Tyco Healthcare | Jul 20, 2004 | SESE |
| K041243 | DOVER RED RUBBER ROBINSON CATHETER | Tyco Healthcare | Jul 7, 2004 | SESE |
| K033719 | BARD TIGERTAIL URETERAL CATHETER | C.R. Bard, Inc. | Feb 4, 2004 | SESE |
| K032710 | CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT | Apogee Medical, Inc. | Jan 9, 2004 | SESE |
| K033023 | INTERMITTENT URETHRAL CATHETERS | Rusch Intl. | Dec 23, 2003 | SESE |
| K022135 | URETERAL ACCESS SHEATH SET (UASS) | Boston Scientific Corp | Sep 13, 2002 | SESE |
| K013483 | INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT | Hollister, Inc. | Jan 14, 2002 | SESE |
| K013345 | INCARE INTERMITTENT CATHETER | Hollister, Inc. | Jan 7, 2002 | SESE |
| K011965 | IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1 | Boston Scientific Corp | Jul 13, 2001 | SESE |
| K010339 | ENDOCARE PERCUTANEOUS ACCESS SET | Endocare, Inc. | Mar 7, 2001 | SESE |
| K002396 | ENDOCARE PERCUTANEOUS ACCESS SET | Endocare, Inc. | Oct 13, 2000 | SESE |
| K001583 | ISLAND BIOSURGICAL BNS KIT #3 | Island Biosurgical, LLC | Jul 13, 2000 | SESE |
| K000723 | HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC) | Rochester Medical Corp. | May 19, 2000 | SESE |
| K000070 | FLOCATH | Rusch Intl. | Feb 18, 2000 | SESE |
| K965229 | IMAGER TORQUE CATHETER | Boston Scientific Corp | Mar 4, 1997 | SESE |
| K951260 | URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT | Biosearch Medical Products, Inc. | Sep 27, 1995 | SESE |
| K945061 | NOPROFILE OLBERT CATHETER SYSTEM | Meadox Surgimed, Inc. | Mar 9, 1995 | SESE |
| K922527 | BARD URODYNAMIC CATHETERIZATION PROCEDURE TRAY | C.R. Bard, Inc. | Apr 14, 1994 | SEKD |
| K933109 | 4SURE URO-LINK UROLOGICAL PROCEDURE TRAYS | Boston Pacific Medical, Inc. | Mar 28, 1994 | SEKD |
| K915459 | FLOWMATE HAND PUMP | Psi Medical Products, Inc. | Feb 15, 1994 | SESE |
| K931195 | PERCUTANEOUS DRAINAGE LOOP CATHETER SET | Cook Urological, Inc. | Dec 22, 1993 | SESE |
| K933400 | KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMPERATURE SENSOR | Kendall Healthcare Products Co. Div.Of Tyco Health | Nov 15, 1993 | SESE |
| K930608 | ONIK-COHEN ACCESS SET | Cook Urological, Inc. | Jul 9, 1993 | SESE |
| K923906 | FOLEY INSERTION TRAY | Kit Pak, Inc. | Jun 22, 1993 | SEKD |
| K922051 | KIT PAK'S FLUSHING KIT | Kit Pak, Inc. | Jun 17, 1993 | SESK |
| K922431 | BARD LATEX URINARY CATHETERS | C.R. Bard, Inc. | Mar 25, 1993 | SESK |
| K923607 | RADIFOCUS GUIDE WIRE M | Terumo Medical Corp. | Oct 2, 1992 | SESE |
| K921054 | KENDALL MOD. PEDIATRIC ULTRAMER POLYURETHANE CATH. | Kendall Healthcare Products Co. Div.Of Tyco Health | Sep 23, 1992 | SESE |
| K921415 | IRRIGATION TUBING SET | Psi Medical Products, Inc. | Sep 4, 1992 | SESE |
| K921253 | INSTRUMENT IRRIGATION PUMP | Psi Medical Products, Inc. | Aug 6, 1992 | SESE |
| K914933 | HEART PACK III | Westmark Hospital Supplies | Jan 31, 1992 | SEKD |
| K912851 | NAUDE URETHRAL STENT | Cook Urological, Inc. | Jan 30, 1992 | SESE |
| K911242 | KENDALL PEDIATRIC ULTRAMER POLYURETHANE CATHETER | Kendall Healthcare Products Co. Div.Of Tyco Health | Apr 25, 1991 | SESE |
| K900509 | NORTA SILICONE ELASTOMER COATED LATEX BALLOON CATH | Medical Latex Corp. | Dec 14, 1990 | SESE |
| K904734 | PHARMASEAL DISPOSABLE ABDOMINAL TROCAR | Baxter Healthcare Corp | Nov 21, 1990 | SESE |
| K896729 | NELATON-, FEMALE - OR TIEMANN CATHETER | Unoplast A/S | Nov 5, 1990 | SESE |
| K896750 | LOFRIC(R), LOFRIC(R) CATH-KIT | Astra Meditec AB | Aug 6, 1990 | SESE |
| K901738 | SELFCATH | Vitaid, Ltd. | Jun 27, 1990 | SESE |
| K900229 | BARD CONFORMACATH FOLEY CATHETER | C.R. Bard, Inc. | Apr 17, 1990 | SESE |
| K900022 | BJ STAR ALL SILICONE FOLEY BALLOON CATHETER | B.J. Star, Inc. | Mar 15, 1990 | SESE |
| K896726 | 4 SURE EXTERNAL MALE CATHETER | The Boston & Pacific Co., Inc. | Feb 26, 1990 | SESE |
| K896784 | DISPOSABLE URODYNAMIC CATHETER SET | Life-Tech Intl., Inc. | Feb 16, 1990 | SESE |
| K896725 | 4 SURE UROLOGICAL CATHETER | The Boston & Pacific Co., Inc. | Feb 16, 1990 | SESE |
| K896053 | ALL SILICONE FOLEY CATHETER | Rochester Medical Corp. | Feb 12, 1990 | SESE |
| K895548 | CONVEEN INTERMITTENT CATHETERS | Coloplast A/S | Feb 9, 1990 | SESE |
| K896385 | URETERAL ACCESS SET | Applied Urology, Inc. | Jan 22, 1990 | SESE |
| K896213 | Y-TYPE TUR/CONTINUOUS BLADDER IRRIGATION SET | Westmark, Sterile Packing Systems, Inc. (Sps) | Jan 18, 1990 | SESE |
| K896211 | CYSTOSCOPY/IRRIGATION SET | Westmark, Sterile Packing Systems, Inc. (Sps) | Jan 18, 1990 | SESE |
| K896208 | CYSTO PUMP DRAINAGE BAG | Westmark, Sterile Packing Systems, Inc. (Sps) | Jan 18, 1990 | SESE |
| K890400 | MODIFIED URINARY CATHETER INTRODUCER (UCI) | Go Medical Industries Pty. , Ltd. | Sep 12, 1989 | SESE |
| K893390 | MODIFIED PRISTINE CULTURE CATHETER | Hml Medical, Inc. | Sep 7, 1989 | SESE |
| K892436 | KENDALL CURITY IRRIGATION SYRINGE | The Kendal Co. | Jul 14, 1989 | SESE |
| K892691 | CATHETERS, MALE, FEMALE | Zinnanti Surgical Instruments, Inc. | Jun 23, 1989 | SESE |
| K885202 | 16 LONG CATHETER W/ADAPTER, 14 FR AND 12 FR | Coeur Laboratories, Inc. | Jan 31, 1989 | SESE |
| K883763 | ACME GUIDEWIRES FOR PERCUTANEOUS INSERTION OF CATH | Acme-Monaco Corp. | Nov 18, 1988 | SESE |
| K881981 | ASSIST(TM) ASEPTIC SYRINGE IRRIGATION SYSTEM | Ryder Intl. Corp. | Aug 2, 1988 | SESE |
| K881781 | CATHETER STRAP | Baxter Healthcare Corp | Aug 2, 1988 | SESE |
| K881363 | SYRINGE PREFILLED WITH WATER | I M, Inc. | Jun 23, 1988 | SESE |
| K881646 | UROLOGICAL CATHETER | Coeur Laboratories, Inc. | Jun 16, 1988 | SESE |
| K880100 | COOK UROLOGICAL WIRE GUIDE W/HYDROMER COATING | Cook Urological, Inc. | Mar 15, 1988 | SESE |
| K875383 | LAKE CATHETER CARE KITS (MODIFICATION) | Lake Medical Products, Inc. | Mar 9, 1988 | SESD |
| K874112 | VAN-TEC DOUBLE OCCLUSION BALLOON CATHETER | Van-Tec, Inc. | Feb 11, 1988 | SESE |
| K874682 | MMG CATHETER PLUG W/DRAINAGE TUBE COVER | Medical Marketing Group | Jan 27, 1988 | SESE |
| K874525 | MODIFIED FOLEY CATHETER/TEMPERATURE SENSOR | Mon-A-Therm, Inc. | Jan 6, 1988 | SESE |
| K874312 | ACKRAD RETROGRADE URETHROGRAPHY SET | Ackrad Laboratories | Dec 29, 1987 | SESE |
| K874293 | ACKRAD V/CUG VOIDING CYSTOURETHROGRAPHY SET | Ackrad Laboratories | Dec 29, 1987 | SESE |
| K873448 | FOLEY CATHETER TEMPERATURE SENSOR | Respiratory Support Products, Inc. | Dec 7, 1987 | SESE |
| K874517 | PHARMASEAL RUBBER URETHRAL CATHETER | American Pharmaseal Div. Ahsc | Dec 3, 1987 | SESE |
| K873287 | IRRIGATION TRAY (W/120CC OF STERILE NORMAL SALINE) | Todd Medical, Inc. | Nov 13, 1987 | SESD |
| K873435 | LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET | Level 1 Technologies, Inc. | Oct 5, 1987 | SESE |
| K872750 | LAKE CATHETER CARE KIT | Lake Medical Products, Inc. | Sep 3, 1987 | SESE |
| K871429 | ANTIMICROBIAL FOLEY CATHETER | American Pharmaseal Div. Ahsc | Aug 10, 1987 | SESE |
| K864592 | JUDD URETHAL CATHETER CONTAINER | Phil Judd, Inc. | Jun 24, 1987 | SESE |
| K870165 | FOLEY CATHETER | Acorn Medical Products | Apr 17, 1987 | SESE |
| K871297 | KADIR HI-TORQUE GUIDE WIRE | Argon Medical Corp. | Apr 10, 1987 | SESE |
| K870977 | PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE | American Pharmaseal Div. Ahsc | Apr 1, 1987 | SESE |
| K870557 | VAN-TEC PUMPING SYSTEM | Van-Tec, Inc. | Mar 30, 1987 | SESE |
| K870694 | VAN-TEC OPEN ENDED CONE TIP URETERAL CATHETER | Van-Tec, Inc. | Mar 10, 1987 | SESE |
| K864736 | AKRO-SIL PLUS | Akron Catheter, Inc. | Dec 24, 1986 | SESE |
| K861699 | CATHETER VALVES KV 100 & KV 100EH | Max Staubli , Ltd. | Nov 19, 1986 | SESE |
| K862098 | PRISTINE/BLOOMING/PRISTINE BLOOMING CULTURE CATH | Hall/Mccollum Laboratories, Inc. | Nov 12, 1986 | SESE |
| K863082 | COOK-VPI INTERMITTENT CATHETER | Cook Urological, Inc. | Nov 7, 1986 | SESE |
| K863958 | TUBEGRIPPER, UROLOGICAL CATHETER & ACCESSORY | Cathaid, Inc. | Nov 4, 1986 | SESE |
| K863354 | BIO-GUARD AB COATED CATHETER | Cook Urological, Inc. | Nov 4, 1986 | SESE |
| K863517 | FOLEY CATHETERS | Instrumentation Industries, Inc. | Oct 31, 1986 | SESE |
| K863282 | CARE + PLUS CATHETER CARE TRAY | Welmed Systems, Inc. | Oct 31, 1986 | SESE |
| K863281 | CARE + PLUS IRREGATION TRAY | Welmed Systems, Inc. | Oct 31, 1986 | SESE |
| K863302 | MODIFIED FOLEY CATHETER | Sheridan Catheter Corp. | Oct 3, 1986 | SESE |
| K862484 | HCI Y-CONNECTOR | Hospital Concepts, Inc. | Sep 9, 1986 | SESE |
| K860325 | PRISTINE CULTURE CATHETER | Hall/Mccollum Laboratories, Inc. | Aug 19, 1986 | SESE |
| K862124 | POLYMED LABORATORIES ALL SILICONE FOLEY CATHETER | Polymed Laboratories | Aug 14, 1986 | SESE |
| K861200 | UROTOPO CATHETER | Houston Biomedical, Inc. | Apr 23, 1986 | SESE |
| K861181 | NORTA TEFLON COATED LATEX BALLOON CATHETERS | Beiersdorf, Inc. | Apr 8, 1986 | SESE |
| K860265 | TELESCOPE PROTECTION TUBE | R. J. Ltd., Ind. | Apr 7, 1986 | SESE |
| K860337 | VAN-TEC URETERAL ANESTHE. STONE DISPLACEMENT CATH. | Van-Tec, Inc. | Mar 25, 1986 | SESE |
| K860484 | CURITY & KENGUARD SILICONE COATED FOLEY CATHETER | The Kendal Co. | Mar 11, 1986 | SESE |
| K855143 | ANGIOMED EXCHANGE DRAINAGE CATHETER SETS | Angiomed U.S., Inc. | Mar 11, 1986 | SESE |
| K855076 | ANGIOMED URETER DIATION SETS | Angiomed U.S., Inc. | Mar 11, 1986 | SESE |
| K854625 | UROTEC CLOSED IRRIGATIION SYRINGE | Urotec Systems Corp. | Mar 4, 1986 | SESE |
| K855140 | ANGIOMED RENAL DILATION SET | Angiomed U.S., Inc. | Feb 24, 1986 | SESE |
| K855077 | ANGIOMED HARZMANN DISCS | Angiomed U.S., Inc. | Jan 21, 1986 | SESE |
| K854443 | O'NEIL URINARY CATHETER INTRODUCER | Pennine Medical , Ltd. | Jan 8, 1986 | SESE |
| K852084 | KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMP | The Kendal Co. | Sep 20, 1985 | SESE |
| K853207 | PHARM 100% SILICONE FOLEY CATH TEMPERATURE PROBE | American Pharmaseal Div. Ahsc | Sep 12, 1985 | SESE |
| K853337 | TROCAR/CANNULA/SHEATH SET | American Edwards Laboratories | Aug 23, 1985 | SESE |
| K851160 | VAN-TEC GUIDE WIRE W/HYDROMER COATING | Van-Tec, Inc. | Jul 29, 1985 | SESE |
| K851857 | UROLOGICAL CATHETER & ACCESSORIES FOLEY CATHETER | Sheridan Catheter Corp. | Jul 15, 1985 | SESE |
| K851684 | UROTEC/FRANKLIN SOFT SIMPLASTIC CATHETER | Urotec Systems Corp. | Jul 2, 1985 | SESE |
| K851180 | IRRIGATION TRAY | Pace Pharmaceutical Services, Inc. | Apr 25, 1985 | SESE |
| K851179 | CATHETER CARE TRAY | Pace Pharmaceutical Services, Inc. | Apr 25, 1985 | SESE |
| K850790 | DIAFLEX OCCLUSION BALLOON CATHETER | American Edwards Laboratories | Mar 25, 1985 | SESE |
| K850335 | URETEROSCOPY CATHETER | Inmed Corp. | Mar 12, 1985 | SESE |
| K850285 | GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY | Premium Plastics, Inc. | Feb 28, 1985 | SESE |
| K842420 | NORTA SILICONIZED LATEX BALLOON CATH. | Beiersdorf, Inc. | Nov 21, 1984 | SESE |
| K842866 | URETHRAL CATHETERIZATION TRAY | Inmed Corp. | Sep 10, 1984 | SESE |
| K842228 | AIMED FOLEY CATHETER VARIOUS SIZES | Tech-Cons Ltd., Intl. | Sep 10, 1984 | SESE |
| K842890 | PERCUFIX CATHETER CUFF | Medi-Tech, Inc. | Sep 4, 1984 | SESE |
| K841769 | INTERMITTENT URETHRAL CATHETER TRAY | Seamless Hospital Products Co. | Aug 24, 1984 | SESE |
| K841941 | VAN-TEC OCCLUSION BALLOON CATHETER | Van-Tec, Inc. | Aug 8, 1984 | SESE |
| K841819 | CORPAK FOLEY CATH TRAY W/16FR. TEFLON | Corpak Co. | Jul 19, 1984 | SESE |
| K841678 | STERILE, FOLEY CATHETERS W/PTFE COAT | Abco Dealers, Inc. | Jul 19, 1984 | SESE |
| K841511 | HAEMATURIA CATHETERS | Warne Surgical Products, Ltd. | Jul 12, 1984 | SESE |
| K841544 | AMER. PHARMASEAL SILICONIZED LATEX | American Pharmaseal Div. Ahsc | Jul 9, 1984 | SESE |
| K841727 | UROLOGICAL CATHETER & ACCESSORIES | Research Medical, Inc. | Jun 7, 1984 | SESE |
| K841485 | UROLOGICAL KIT W/STERILE, WATER-FILL | Medline Industries, Inc. | May 9, 1984 | SESE |
| K840839 | MMG FOLEY CATHETER | Medical Technologies of Georgia | Apr 17, 1984 | SESE |
| K832363 | FOLEY CATHETERIZATION TRAY-VARIOUS | Inmed Corp. | Mar 7, 1984 | SESE |
| K834438 | TEMPERATURE SENSING FOLEY CATHETER | C.R. Bard, Inc. | Feb 4, 1984 | SESE |
| K833719 | PREPACELL THIN NEEDLE ASPIRATION TRAY | Applied Medical Devices, Inc. | Jan 25, 1984 | SESE |
| K833432 | CATHETER INSERTION KIT | Clinipad Corp. | Dec 28, 1983 | SESE |
| K833790 | CURITY 100% SILICONE COUDE' CATHETER | The Kendal Co. | Dec 27, 1983 | SESE |
| K832389 | CATHETER CARE TRAY | Inmed Corp. | Sep 19, 1983 | SESE |
| K832692 | CURITY CATHETER STRAP | The Kendal Co. | Sep 12, 1983 | SESE |
| K831743 | STERILE FOLEY CATHETERS & UROLOGICAL | Electromedics, Inc. | Sep 12, 1983 | SESE |
| K831567 | FOLEY-TEMP | Mallinckrodt Critical Care | Aug 10, 1983 | SESE |
| K832165 | IMPROVED SILICATH SILICONE ELASTOMER | Travenol Laboratories, S.A. | Aug 8, 1983 | SESE |
| K831244 | URETERAL STONE EXTRACTOR CATHETER | American Edwards Laboratories | Jun 17, 1983 | SESE |
| K831369 | LATEX URINARY CATHETERS | Wayne Surgical Products | May 27, 1983 | SESE |
| K830359 | STERILE CATHERIZATION PROCEDURE TRAYS | Welcon, Inc. | Mar 17, 1983 | SESE |
| K830444 | STERILE, ALL PURPOSE URETHRAL CATHETER | Abco Dealers, Inc. | Mar 9, 1983 | SESE |
| K823818 | CATHETER HOLDER | Danek Medical, Inc. | Jan 9, 1983 | SESE |
| K821818 | RETRIEVAL BALLOONS | American Endoscopy, Inc. | Sep 24, 1982 | SESE |
| K821970 | DYNACOR URETHRAL CATHETER TRAY | Medline Industries, Inc. | Jul 21, 1982 | SESE |
| K821745 | BARDEX ALL SILICONE PEDIATRIC CATHETER | C.R. Bard, Inc. | Jun 24, 1982 | SESE |
| K821272 | BN-74 COATED BARDEX ALL SILICONE CATH | C.R. Bard, Inc. | Jun 22, 1982 | SESE |
| K820987 | FOLEY INSERTION TRAYS W/OVERWRAY | Inmed Corp. | May 13, 1982 | SESE |
| K820838 | CURITY ECONOMY I CYSTOSCOPY | The Kendal Co. | May 11, 1982 | SESE |
| K820868 | URETERAL CATHETER CONNECTOR | Van-Tec, Inc. | Apr 26, 1982 | SESE |
| K820866 | URETERAL CATHETER CONNECTING TUBE | Van-Tec, Inc. | Apr 26, 1982 | SESE |
| K820239 | RETRIEVAL FORCEPS | American Endoscopy, Inc. | Mar 26, 1982 | SESE |
| K820637 | CATH-HOLD | Womco Products | Mar 25, 1982 | SESE |
| K820419 | AM. PH. STERILE SINGLE-USE URETHRAL CATH | American Pharmaseal Div. Ahsc | Mar 23, 1982 | SESE |
| K820313 | VPI-FAIR URETHRAL STENT | Vance Products, Inc. | Mar 1, 1982 | SESE |
| K812995 | VANCE-JACOBELLIS MICROHEMATURIA CATHETER | Vance Products, Inc. | Mar 1, 1982 | SESE |
| K812887 | ROBINSON CATHETERS NON-STERILE | Abco Dealers, Inc. | Nov 17, 1981 | SESE |
| K811924 | PRE-FILLED SYRINGE & CYSTOFLO URINARY BG | Travenol Laboratories, S.A. | Nov 10, 1981 | SESE |
| K812281 | TOUCHLESS HOME-CATH | Diamed Division Ill. Tool Works, Inc. | Oct 13, 1981 | SESE |
| K811277 | CATH-DAP | Northwest Alabama Urological Assoc. | Jul 20, 1981 | SESE |
| K810690 | CURITY 100% SILICONE SAFETY INDICATOR | The Kendal Co. | Apr 23, 1981 | SESE |
| K810249 | TRAY, CATHERIZATION, URETHRAL | Megaplast, Inc. | Apr 7, 1981 | SESE |
| K810630 | SILICONE ELASTOMER COATED LATEX FOLEY | G.D. Searle and Co. | Mar 31, 1981 | SESE |
| K810372 | VANCE DEFLECTABLE BIOPSY BRUSH SET | Vance Products, Inc. | Mar 20, 1981 | SESE |
| K810367 | KISH URETHRAL ILLUMINATED CATHETER SET | Vance Products, Inc. | Mar 20, 1981 | SESE |
| K810281 | UROLOGICAL CATHETERS | Latex Ind., Inc. | Feb 25, 1981 | SESE |
| K810216 | ARGYLE ROB-NELS | Sherwood Medical Co. | Feb 9, 1981 | SESE |
| K803259 | CLOSED SYSTEM URETHRAL CATHETERIZ. SET | Medical Devices, Inc. | Jan 9, 1981 | SESE |
| K803062 | CATH-SECURE | Melissa C. Johnson | Jan 7, 1981 | SESE |
| K802878 | K-KATH URETHRAL CATHETER INTRODUCER | B&K Medical | Jan 2, 1981 | SESE |
| K803080 | ALL PUPOSE URETHRAL CATHETER | American Hospital Supply Corp. | Dec 22, 1980 | SESE |
| K803079 | FOLEY CATHETER | American Hospital Supply Corp. | Dec 22, 1980 | SESE |
| K802875 | ARGYLE HEMATURIA BALLOON CATHETER | Sherwood Medical Co. | Dec 16, 1980 | SESE |
| K802665 | TOUCHLESS CLEAN-CATH | Diamed Division Ill. Tool Works, Inc. | Nov 12, 1980 | SESE |
| K802516 | FOLEY CATHETER | Abco Dealers, Inc. | Oct 31, 1980 | SESE |
| K801820 | FOLEY CATHETERIZATION TRAY | Abco Dealers, Inc. | Oct 21, 1980 | SESE |
| K801787 | URINARY CATHETER CARE TRAYS #3700&3710 | The Healthcare Group Laboratories, Inc. | Oct 21, 1980 | SESE |
| K801785 | URETHRAL CATHETERIZATION TRAYS | The Healthcare Group Laboratories, Inc. | Oct 21, 1980 | SESE |
| K801786 | URINE COLLECTION CONTAINERS, #3600 &3610 | The Healthcare Group Laboratories, Inc. | Sep 30, 1980 | SESE |
| K802083 | CATHETER INSERTION TRAY | Walpak Co. | Sep 16, 1980 | SESE |
| K801415 | LATEX FOLEY CATHETER (HYDROMER COATED) | G.D. Searle and Co. | Aug 20, 1980 | SESE |
Top Applicants
- 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
