KOD · Class II · 21 CFR 876.5130

FDA Product Code KOD: Catheter, Urological

Leading manufacturers include C.R. Bard, Inc., Abco Dealers, Inc. and Van-Tec, Inc..

238
Total
238
Cleared
90d
Avg days
1976
Since
238 devices
25–48 of 238
Cleared Jan 09, 2004
CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT
K032710
Apogee Medical, Inc.
Gastroenterology & Urology · 129d
Cleared Dec 23, 2003
INTERMITTENT URETHRAL CATHETERS
K033023
Rusch Intl.
Gastroenterology & Urology · 88d
Cleared Sep 13, 2002
URETERAL ACCESS SHEATH SET (UASS)
K022135
Boston Scientific Corp
Gastroenterology & Urology · 74d
Cleared Jan 14, 2002
INCARE ADVANCE
K013483
Hollister, Inc.
Gastroenterology & Urology · 87d
Cleared Jan 07, 2002
INCARE INTERMITTENT CATHETER
K013345
Hollister, Inc.
Gastroenterology & Urology · 90d
Cleared Jul 13, 2001
IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1
K011965
Boston Scientific Corp
Gastroenterology & Urology · 18d
Cleared Mar 07, 2001
ENDOCARE PERCUTANEOUS ACCESS SET
K010339
Endocare, Inc.
Gastroenterology & Urology · 30d
Cleared Oct 13, 2000
ENDOCARE PERCUTANEOUS ACCESS SET
K002396
Endocare, Inc.
Gastroenterology & Urology · 67d
Cleared Jul 13, 2000
ISLAND BIOSURGICAL BNS KIT #3
K001583
Island Biosurgical, LLC
Gastroenterology & Urology · 52d
Cleared May 19, 2000
HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)
K000723
Rochester Medical Corp.
Gastroenterology & Urology · 74d
Cleared Feb 18, 2000
FLOCATH
K000070
Rusch Intl.
Gastroenterology & Urology · 39d
Cleared Mar 04, 1997
IMAGER TORQUE CATHETER
K965229
Boston Scientific Corp
Gastroenterology & Urology · 63d
Cleared Sep 27, 1995
URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT
K951260
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 190d
Cleared Mar 09, 1995
NOPROFILE OLBERT CATHETER SYSTEM
K945061
Meadox Surgimed, Inc.
Gastroenterology & Urology · 146d
Cleared Apr 14, 1994
BARD URODYNAMIC CATHETERIZATION PROCEDURE TRAY
K922527
C.R. Bard, Inc.
Gastroenterology & Urology · 686d
Cleared Mar 28, 1994
4SURE URO-LINK UROLOGICAL PROCEDURE TRAYS
K933109
Boston Pacific Medical, Inc.
Gastroenterology & Urology · 276d
Cleared Feb 15, 1994
FLOWMATE HAND PUMP
K915459
Psi Medical Products, Inc.
Gastroenterology & Urology · 804d
Cleared Dec 22, 1993
PERCUTANEOUS DRAINAGE LOOP CATHETER SET
K931195
Cook Urological, Inc.
Gastroenterology & Urology · 288d
Cleared Nov 15, 1993
KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMPERATURE SENSOR
K933400
Kendall Healthcare Products Co. Div.Of Tyco Health
Gastroenterology & Urology · 126d
Cleared Jul 09, 1993
ONIK-COHEN ACCESS SET
K930608
Cook Urological, Inc.
Gastroenterology & Urology · 154d
Cleared Jun 22, 1993
FOLEY INSERTION TRAY
K923906
Kit Pak, Inc.
Gastroenterology & Urology · 322d
Cleared Jun 17, 1993
KIT PAK'S FLUSHING KIT
K922051
Kit Pak, Inc.
Gastroenterology & Urology · 412d
Cleared Mar 25, 1993
BARD LATEX URINARY CATHETERS
K922431
C.R. Bard, Inc.
Gastroenterology & Urology · 307d
Cleared Oct 02, 1992
RADIFOCUS GUIDE WIRE M
K923607
Terumo Medical Corp.
Gastroenterology & Urology · 78d