Medical Device Manufacturer · US , Spencer , IN

Cook Urological, Inc.

104 submissions · 102 cleared · Since 1986
104
Total
102
Cleared
0
Denied

Cook Urological, Inc. — FDA 510(k) Submissions

Cook Urological, Inc. has submitted 104 FDA 510(k) premarket notifications since 1986, of which 102 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Urological, Dilator, Catheter, Ureteral, Electrosurgical, Cutting & Coagulation & Accessories, Laparoscope, Gynecologic (and Accessories), Stent, Ureteral . Use the specialty filter in the sidebar to narrow results.

104 devices
1–25 of 104
COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)
K102141 · KNA Instrument, Manual,... · Obstetrics & Gynecology
May 2011 281d
3 WAY SILICONE FOLEY BALLOON CATHETER
K091767 · EZL Catheter, Retention Type,... · Gastroenterology & Urology
Oct 2009 114d
COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400
K082939 · KNA Instrument, Manual,... · Obstetrics & Gynecology
Sep 2009 336d
TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER
K082066 · HFE Brush, Endometrial · Obstetrics & Gynecology
Nov 2008 108d
COOK WIRE GUIDES
K082536 · OCY Endoscopic Guidewire,... · Gastroenterology & Urology
Oct 2008 55d
INJEKT FILIFORM INJECTION NEEDLE
K082319 · FBK Endoscopic Injection... · Gastroenterology & Urology
Sep 2008 43d
COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W
K080525 · GEX Powered Laser Surgical... · General & Plastic Surgery
Apr 2008 51d
OPTILITE HOLMIUM LASER FIBERS
K073496 · GEX Powered Laser Surgical... · General & Plastic Surgery
Jan 2008 42d
COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH
K072521 · FFS Image, Illumination,... · Gastroenterology & Urology
Nov 2007 74d
SYDNEY IVF SPERM CRYOPRESERVATION BUFFER
K061371 · MQL Media, Reproductive · Obstetrics & Gynecology
Aug 2006 92d
SONOHYSTEROGRAPHY BIOPSY DEVICE
K060908 · PGK Cannula, Injector,... · Obstetrics & Gynecology
Jun 2006 87d
COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH
K043418 · FED Endoscopic Access... · Gastroenterology & Urology
Mar 2005 108d
INTRAUTERINE VENOGRAM NEEDLE SET
K041062 · LKF Cannula,... · Obstetrics & Gynecology
Oct 2004 161d
COOK URETERAL BALLOON DILATION CATHETER SET
K040127 · EZN Dilator, Catheter, Ureteral · Gastroenterology & Urology
Apr 2004 76d
SYDNEY IVF PVP
K031304 · MQL Media, Reproductive · Obstetrics & Gynecology
Mar 2004 334d
MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES,
K033903 · MQH Microtools, Assisted... · Obstetrics & Gynecology
Jan 2004 30d
PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES)
K033904 · MQH Microtools, Assisted... · Obstetrics & Gynecology
Jan 2004 30d
COOK NEPHROSTOMY DILATION BALLOON CATHETER SET
K024050 · LJE Catheter, Nephrostomy · Gastroenterology & Urology
Feb 2003 80d
SYDNEY IVF HYALURONIDASE
K023353 · MQL Media, Reproductive · Obstetrics & Gynecology
Dec 2002 74d
COOK INJECTION NEEDLE
K022484 · FBK Endoscopic Injection... · Gastroenterology & Urology
Oct 2002 88d
SYDNEY IVF CULTURE OIL
K022002 · MQL Media, Reproductive · Obstetrics & Gynecology
Aug 2002 54d
PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES)
K014160 · MQG Accessory, Assisted... · Obstetrics & Gynecology
Feb 2002 51d
COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT
K011157 · MQL Media, Reproductive · Obstetrics & Gynecology
May 2001 17d
SPECTRUM SILICONE FOLEY CATHETER
K000251 · MJC Catheter, Urological... · Gastroenterology & Urology
Aug 2000 216d
OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING
K994417 · MQE Needle, Assisted... · Obstetrics & Gynecology
Mar 2000 63d

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