Cook Urological, Inc.

FDA 510(k) & PMA Approved Devices — 104 products

Total Devices104

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K102141	COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)	KNA	2011-05-06	View
510(k)	K091767	3 WAY SILICONE FOLEY BALLOON CATHETER	EZL	2009-10-09	View
510(k)	K082939	COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400	KNA	2009-09-03	View
510(k)	K082066	TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER	HFE	2008-11-07	View
510(k)	K082536	COOK WIRE GUIDES	OCY	2008-10-27	View
510(k)	K082319	INJEKT FILIFORM INJECTION NEEDLE	FBK	2008-09-25	View
510(k)	K080525	COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W	GEX	2008-04-17	View
510(k)	K073496	OPTILITE HOLMIUM LASER FIBERS	GEX	2008-01-23	View
510(k)	K072521	COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH	FFS	2007-11-20	View
510(k)	K061371	SYDNEY IVF SPERM CRYOPRESERVATION BUFFER	MQL	2006-08-17	View
510(k)	K060908	SONOHYSTEROGRAPHY BIOPSY DEVICE	PGK	2006-06-29	View
510(k)	K043418	COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH	FED	2005-03-31	View
510(k)	K041062	INTRAUTERINE VENOGRAM NEEDLE SET	LKF	2004-10-01	View
510(k)	K040127	COOK URETERAL BALLOON DILATION CATHETER SET	EZN	2004-04-06	View
510(k)	K031304	SYDNEY IVF PVP	MQL	2004-03-23	View
510(k)	K033904	PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES)	MQH	2004-01-16	View
510(k)	K033903	MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES,	MQH	2004-01-16	View
510(k)	K024050	COOK NEPHROSTOMY DILATION BALLOON CATHETER SET	LJE	2003-02-27	View
510(k)	K023353	SYDNEY IVF HYALURONIDASE	MQL	2002-12-20	View
510(k)	K022484	COOK INJECTION NEEDLE	FBK	2002-10-25	View