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. |
|
|