Medical Device Manufacturer · US , Bloomington , IN

Cook Incorporated - FDA 510(k) Cleared Devices

175 submissions · 153 cleared · Since 2006
175
Total
153
Cleared
1
Denied

FDA 510(k) cleared devices by Cook Incorporated Obstetrics & Gynecology

20 devices
1-20 of 20
Cleared Mar 08, 2024
Nest VT Vitrification Device
K233177 · MQK
Obstetrics & Gynecology · 162d
Cleared Oct 28, 2022
Bakri Essential Postpartum Balloon
K223098 · OQY
Obstetrics & Gynecology · 28d
Cleared May 17, 2019
Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer...
K191015 · MQF
Obstetrics & Gynecology · 30d
Cleared Mar 29, 2019
Intrauterine Access Balloon Catheter, Selective Salpingography Catheter
K181770 · LKF
Obstetrics & Gynecology · 269d
Cleared Oct 26, 2018
Cook Silicone Balloon HSG Catheter
K180291 · LKF
Obstetrics & Gynecology · 267d
Cleared Oct 26, 2018
Margolin HSG Cannula, Goldstein Sonohysterography Catheter
K180300 · LKF
Obstetrics & Gynecology · 266d
Cleared Oct 24, 2018
Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™...
K180302 · MQF
Obstetrics & Gynecology · 264d
Cleared Jul 12, 2018
Modified Novy Cornual Cannulation Set
K180552 · MOV
Obstetrics & Gynecology · 133d
Cleared Apr 13, 2018
Pivet and Soft-Pass Embryo Transfer Catheter Sets
K173103 · MQF
Obstetrics & Gynecology · 196d
Cleared Apr 11, 2018
Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter
K173686 · MQF
Obstetrics & Gynecology · 131d
Cleared Feb 15, 2018
Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube...
K171604 · LKF
Obstetrics & Gynecology · 259d
Cleared Jan 10, 2018
Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans...
K172051 · MQF
Obstetrics & Gynecology · 188d
Cleared Dec 21, 2017
Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination...
K172321 · MQF
Obstetrics & Gynecology · 142d
Cleared Jul 14, 2017
Soules Intrauterine Insemination Catheter
K163318 · MQF
Obstetrics & Gynecology · 233d
Cleared May 24, 2017
Tao Brush I.U.M.C. Endometrial Sampler
K170603 · HFE
Obstetrics & Gynecology · 84d
Cleared Mar 31, 2017
Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation...
K170622 · OQY
Obstetrics & Gynecology · 30d
Cleared Oct 06, 2016
uVue HSG/SHG Catheter
K160217 · LKF
Obstetrics & Gynecology · 251d
Cleared Jan 08, 2016
Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction...
K151018 · MQH
Obstetrics & Gynecology · 267d
Cleared Dec 18, 2015
Flexipet Denuding Pipette, Flexipet Manipulation Pipette
K150748 · MQH
Obstetrics & Gynecology · 270d
Cleared Dec 23, 2008
COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES
K081768 · NAJ
Obstetrics & Gynecology · 186d
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