Medical Device Manufacturer · US , Bloomington , IN

Cook Ob/Gyn

43 submissions · 43 cleared · Since 1985
43
Total
43
Cleared
0
Denied

Cook Ob/Gyn — FDA 510(k) Submissions

Cook Ob/Gyn has submitted 43 FDA 510(k) premarket notifications since 1985, of which 43 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Assisted Reproduction, Laparoscope, Gynecologic (and Accessories), Media, Reproductive, Cap, Cervical, Cannula, Intrauterine Insemination . Use the specialty filter in the sidebar to narrow results.

43 devices
1–25 of 43
BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500
K062438 · KNA Instrument, Manual,... · Obstetrics & Gynecology
Oct 2006 67d
SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT
K030441 · MQL Media, Reproductive · Obstetrics & Gynecology
Aug 2003 199d
SYDNEY IVF EMBRYO BIOPSY MEDIUM
K023850 · MQL Media, Reproductive · Obstetrics & Gynecology
Jan 2003 64d
TAMPONADE UTERINE BALLOON CATHETER SET
K013597 · KNA Instrument, Manual,... · Obstetrics & Gynecology
Apr 2002 168d
COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM,
K002385 · MQL Media, Reproductive · Obstetrics & Gynecology
Sep 2000 45d
COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT
K002383 · MQL Media, Reproductive · Obstetrics & Gynecology
Sep 2000 40d
TRANSMYOMETRIAL EMBRYO TRANSFER SET
K983595 · MQF Catheter, Assisted... · Obstetrics & Gynecology
Feb 1999 118d
INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING
K983596 · MQH Microtools, Assisted... · Obstetrics & Gynecology
Feb 1999 115d
COOK MINI-INCUBATOR
K983642 · MQG Accessory, Assisted... · Obstetrics & Gynecology
Feb 1999 108d
OVUM PICK-UP ASPIRATION NEEDLES
K983593 · MQE Needle, Assisted... · Obstetrics & Gynecology
Jan 1999 100d
GIFT CATHETER SET/S
K983590 · MQF Catheter, Assisted... · Obstetrics & Gynecology
Dec 1998 69d
INTRATUBAL TRANSFER SETS
K983591 · MQF Catheter, Assisted... · Obstetrics & Gynecology
Dec 1998 69d
EMBRYO TRANSFER CATHETERS/SETS
K983594 · MQF Catheter, Assisted... · Obstetrics & Gynecology
Dec 1998 69d
HYSTEROSCOPIC GIFT CATHETER SETS
K983587 · MQF Catheter, Assisted... · Obstetrics & Gynecology
Dec 1998 64d
COOK TEST TUBE HEATER
K983609 · MQG Accessory, Assisted... · Obstetrics & Gynecology
Dec 1998 63d
NOVY CORNUAL CANNULATION SET
K931476 · MOV Catheters, Salpingography · Obstetrics & Gynecology
Jul 1995 856d
IUMC ENDOMETRIAL SAMPLER
K941298 · HFE Brush, Endometrial · Obstetrics & Gynecology
Feb 1995 333d
TUBAL LUMEN SUPPORT
K932114 · HFJ Prosthesis, Fallopian Tube · Obstetrics & Gynecology
Sep 1994 512d
DISPOSABLE LAPAROSCOPIC SWAB WITH REUSABLE HANDLE
K943970 · GCJ Laparoscope, General &... · General & Plastic Surgery
Sep 1994 22d
STOVALL ENDOMETRIAL BRUSH
K911620 · HFE Brush, Endometrial · Obstetrics & Gynecology
Jun 1994 1170d
INSEMI-CATH
K931630 · MFD Cannula, Intrauterine... · Obstetrics & Gynecology
Apr 1994 382d
DETECT (TM) CYTOLOGY BRUSH
K933415 · HHT Spatula, Cervical,... · Obstetrics & Gynecology
Feb 1994 227d
COOK ASPIRATION UNIT
K930900 · JCX Apparatus, Suction, Ward... · General & Plastic Surgery
Jul 1993 150d
JANSEN-ANDERSON INSEMINATION SET
K914150 · MFD Cannula, Intrauterine... · Obstetrics & Gynecology
Sep 1992 352d
LAPAROSTAT(TM)
K913300 · HAM Apparatus, Electrosurgical · General & Plastic Surgery
Apr 1992 252d
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