FDA 510(k) Applications Submitted by COOK UROLOGICAL, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K000251 01/27/2000 SPECTRUM SILICONE FOLEY CATHETER COOK UROLOGICAL, INC.
K011157 04/16/2001 COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT COOK UROLOGICAL, INC.
K031304 04/24/2003 SYDNEY IVF PVP COOK UROLOGICAL, INC.
K061371 05/17/2006 SYDNEY IVF SPERM CRYOPRESERVATION BUFFER COOK UROLOGICAL, INC.
K091767 06/17/2009 3 WAY SILICONE FOLEY BALLOON CATHETER COOK UROLOGICAL, INC.
K992070 06/18/1999 COOK ULTRA QUIET VACUUM PUMP & REGULATOR COOK UROLOGICAL, INC.
K022002 06/19/2002 SYDNEY IVF CULTURE OIL COOK UROLOGICAL, INC.
K033903 12/17/2003 MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, COOK UROLOGICAL, INC.
K033904 12/17/2003 PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES) COOK UROLOGICAL, INC.
K080525 02/26/2008 COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W COOK UROLOGICAL, INC.
K082066 07/22/2008 TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER COOK UROLOGICAL, INC.
K102141 07/29/2010 COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED) COOK UROLOGICAL, INC.
K082319 08/13/2008 INJEKT FILIFORM INJECTION NEEDLE COOK UROLOGICAL, INC.
K082536 09/02/2008 COOK WIRE GUIDES COOK UROLOGICAL, INC.
K072521 09/07/2007 COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH COOK UROLOGICAL, INC.
K082939 10/02/2008 COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400 COOK UROLOGICAL, INC.
K073496 12/12/2007 OPTILITE HOLMIUM LASER FIBERS COOK UROLOGICAL, INC.
K060908 04/03/2006 SONOHYSTEROGRAPHY BIOPSY DEVICE COOK UROLOGICAL, INC.
K041062 04/23/2004 INTRAUTERINE VENOGRAM NEEDLE SET COOK UROLOGICAL, INC.
K043418 12/13/2004 COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH COOK UROLOGICAL, INC.
K990072 01/11/1999 BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SET, ASCEND BALLOON DILATION CATHETERS, BALLOON DILATION C COOK UROLOGICAL, INC.
K040127 01/21/2004 COOK URETERAL BALLOON DILATION CATHETER SET COOK UROLOGICAL, INC.
K022484 07/29/2002 COOK INJECTION NEEDLE COOK UROLOGICAL, INC.
K023353 10/07/2002 SYDNEY IVF HYALURONIDASE COOK UROLOGICAL, INC.
K024050 12/09/2002 COOK NEPHROSTOMY DILATION BALLOON CATHETER SET COOK UROLOGICAL, INC.
K014160 12/19/2001 PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES) COOK UROLOGICAL, INC.
K994417 12/29/1999 OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING COOK UROLOGICAL, INC.
K960878 03/04/1996 MAHLER ABDOMINAL WALL ELEVATOR COOK UROLOGICAL, INC.
K961933 05/17/1996 CIRCLE NEPHROSTOMY CATHETER SET COOK UROLOGICAL, INC.
K952513 05/30/1995 LESE STENTS SETS COOK UROLOGICAL, INC.
K955508 12/01/1995 ROSCH -THURMOND FALLOPIAN TUBE CATHETERIZATION SET COOK UROLOGICAL, INC.
K960768 02/26/1996 LASER FIBER DELIVERY/CLEANING CATHETER COOK UROLOGICAL, INC.
K970041 01/06/1997 ASCEND BALLOON DAILATION CATHETER COOK UROLOGICAL, INC.
K960262 01/18/1996 CORING MORCELLATOR COOK UROLOGICAL, INC.
K960263 01/18/1996 CERVICAL MUCOUS ASPIRATION CATHETER COOK UROLOGICAL, INC.
K960469 02/01/1996 DETECT CYTOLOGY BRUSH II COOK UROLOGICAL, INC.
K961371 04/09/1996 SUBCUTANEOUS URINARY DIVERSON STENT SET COOK UROLOGICAL, INC.
K961446 04/16/1996 AQ HYDROPHILIC STENT COOK UROLOGICAL, INC.
K961904 05/16/1996 AQ HYDROPHILIC DILATORS COOK UROLOGICAL, INC.
K962004 05/22/1996 AQ HYDROPHILIC UROLOGICAL CATHETERS COOK UROLOGICAL, INC.
K952527 06/01/1995 BALLOON UTERINE STENT COOK UROLOGICAL, INC.
K972647 07/15/1997 CO2 PNEUMO-DISSECTOR COOK UROLOGICAL, INC.
K972977 08/11/1997 INSULATOR WIRE GUIDE COOK UROLOGICAL, INC.
K954903 10/25/1995 PEDI VAGINAL ASPIRATOR COOK UROLOGICAL, INC.
K955618 12/11/1995 BIPOLAR CUTTER COOK UROLOGICAL, INC.


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