Cook Urological, Inc. - FDA 510(k) Cleared Devices
Recent clearances: COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED), 3 WAY SILICONE FOLEY BALLOON CATHETER, COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400
104
Total
102
Cleared
0
Denied
FDA 510(k) Regulatory Record - Cook Urological, Inc. Gastroenterology & Urology ✕
56 devices
Cleared
Oct 09, 2009
3 WAY SILICONE FOLEY BALLOON CATHETER
Gastroenterology & Urology
114d
Cleared
Oct 27, 2008
COOK WIRE GUIDES
Gastroenterology & Urology
55d
Cleared
Sep 25, 2008
INJEKT FILIFORM INJECTION NEEDLE
Gastroenterology & Urology
43d
Cleared
Nov 20, 2007
COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH
Gastroenterology & Urology
74d
Cleared
Mar 31, 2005
COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH
Gastroenterology & Urology
108d
Cleared
Apr 06, 2004
COOK URETERAL BALLOON DILATION CATHETER SET
Gastroenterology & Urology
76d
Cleared
Feb 27, 2003
COOK NEPHROSTOMY DILATION BALLOON CATHETER SET
Gastroenterology & Urology
80d
Cleared
Oct 25, 2002
COOK INJECTION NEEDLE
Gastroenterology & Urology
88d
Cleared
Aug 30, 2000
SPECTRUM SILICONE FOLEY CATHETER
Gastroenterology & Urology
216d
Cleared
Mar 25, 1999
BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SET, ASCEND...
Gastroenterology & Urology
73d
Cleared
Oct 10, 1997
INSULATOR WIRE GUIDE
Gastroenterology & Urology
60d
Cleared
Mar 19, 1997
ASCEND BALLOON DAILATION CATHETER
Gastroenterology & Urology
72d
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