Medical Device Manufacturer · US , Bloomington , IN

Cook Ob/Gyn - FDA 510(k) Cleared Devices

43 submissions · 43 cleared · Since 1985
43
Total
43
Cleared
0
Denied
43 devices
26-43 of 43
Cleared Feb 14, 1992
SOF-FLEX LAPAROSCOPIC BASKET
K913299 · HET
Obstetrics & Gynecology · 204d
Cleared Jul 26, 1991
MAJOLI UTERINE MANIPULATOR/INJECTOR
K911887 · LKF
Obstetrics & Gynecology · 88d
Cleared May 09, 1991
TROCAR ACCESS SHEATH
K905471 · HET
Obstetrics & Gynecology · 154d
Cleared Oct 12, 1990
LAPAROSCOPIC CATHERTER
K903187 · HET
Obstetrics & Gynecology · 85d
Cleared Sep 13, 1990
TEFLON CERVICAL ACCESS SET
K896701 · HDQ
Obstetrics & Gynecology · 289d
Cleared Sep 05, 1990
SPIRTOS COAXIAL CATHETER SET
K896524 · HET
Obstetrics & Gynecology · 294d
Cleared Aug 28, 1990
COAXIAL CATHETER SET
K902694 · HDR
Obstetrics & Gynecology · 70d
Cleared Mar 07, 1990
BALLOON DILATION CATHETER
K896448 · EZN
Gastroenterology & Urology · 118d
Cleared Feb 06, 1990
LAPAROSCOPIC ACCESS SHEATH SET
K897064 · HET
Obstetrics & Gynecology · 48d
Cleared Aug 23, 1989
DIRECTABLE COAXIAL CATHETER SET
K894716 · GCJ
General & Plastic Surgery · 29d
Cleared Jul 14, 1989
ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE
K892846 · HIO
Obstetrics & Gynecology · 87d
Cleared May 23, 1989
SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER
K891290 · HES
Obstetrics & Gynecology · 74d
Cleared Mar 31, 1989
SHEPARD INTRAUTERINE INSEMINATION CATHETER
K890301 · HDR
Obstetrics & Gynecology · 67d
Cleared Nov 14, 1988
STAMEY NEEDLE
K884553 · GEJ
General & Plastic Surgery · 14d
Cleared Oct 03, 1988
FEMALE CONTINENCE DEVICE
K883721 · HHW
Obstetrics & Gynecology · 33d
Cleared Mar 04, 1987
TEFLON UTERINE SOUND
K870550 · HHM
Obstetrics & Gynecology · 22d
Cleared Mar 02, 1987
INTRAUTERINE INSEMINATION CATHETER
K870551 · HDR
Obstetrics & Gynecology · 20d
Cleared Aug 08, 1985
PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHETER SET
K852287 · KOB
Gastroenterology & Urology · 71d
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