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. General & Plastic Surgery ✕
15 devices
Cleared
Apr 17, 2008
COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W
General & Plastic Surgery
51d
Cleared
Jan 23, 2008
OPTILITE HOLMIUM LASER FIBERS
General & Plastic Surgery
42d
Cleared
May 14, 1996
LASER FIBER DELIVERY/CLEANING CATHETER
General & Plastic Surgery
78d
Cleared
Mar 15, 1996
MAHLER ABDOMINAL WALL ELEVATOR
General & Plastic Surgery
11d
Cleared
Jan 22, 1996
BIPOLAR CUTTER
General & Plastic Surgery
42d
Cleared
Apr 18, 1995
BIPOLAR SNARE
General & Plastic Surgery
56d
Cleared
Dec 02, 1994
COOK UROLOGICAL LAPAROSCOPIC TROCAR CLEANER
General & Plastic Surgery
91d
Cleared
Nov 08, 1994
COOK ASPIRATION/IRRIGATION UNIT
General & Plastic Surgery
40d
Cleared
Jul 26, 1994
BIOPLAR FORCEPS
General & Plastic Surgery
20d
Cleared
May 02, 1994
MURDOCH INTRAOPERATIVE LAPAROSCOPIC LENS CLEANER
General & Plastic Surgery
157d
Cleared
Mar 07, 1994
COOK COAGULATOR PROBE
General & Plastic Surgery
88d
Cleared
May 21, 1993
COOK TISSUE MORCELLATOR
General & Plastic Surgery
185d
Cleared
Feb 23, 1993
MAGNETIC RETRIEVER
General & Plastic Surgery
112d
Cleared
Jun 28, 1991
COOK TISSUE MORCELLATOR
General & Plastic Surgery
114d
Cleared
Mar 28, 1991
SURGICAL TISSUE POUCH
General & Plastic Surgery
23d