Cook Urological, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
104
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K102141COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)May 6, 2011
K0917673 WAY SILICONE FOLEY BALLOON CATHETEROctober 9, 2009
K082939COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400September 3, 2009
K082066TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLERNovember 7, 2008
K082536COOK WIRE GUIDESOctober 27, 2008
K082319INJEKT FILIFORM INJECTION NEEDLESeptember 25, 2008
K080525COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30WApril 17, 2008
K073496OPTILITE HOLMIUM LASER FIBERSJanuary 23, 2008
K072521COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATHNovember 20, 2007
K061371SYDNEY IVF SPERM CRYOPRESERVATION BUFFERAugust 17, 2006
K060908SONOHYSTEROGRAPHY BIOPSY DEVICEJune 29, 2006
K043418COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTHMarch 31, 2005
K041062INTRAUTERINE VENOGRAM NEEDLE SETOctober 1, 2004
K040127COOK URETERAL BALLOON DILATION CATHETER SETApril 6, 2004
K031304SYDNEY IVF PVPMarch 23, 2004
K033904PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES)January 16, 2004
K033903MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES,January 16, 2004
K024050COOK NEPHROSTOMY DILATION BALLOON CATHETER SETFebruary 27, 2003
K023353SYDNEY IVF HYALURONIDASEDecember 20, 2002
K022484COOK INJECTION NEEDLEOctober 25, 2002