Cook Ob/Gyn
Medical device manufacturer in Spencer, IN.
43510(k) clearances
0PMA approvals
1recalls
Device types
- MQF Catheter, Assisted Reproduction 5
- HET Laparoscope, Gynecologic (And Accessories) 5
- MQL Media, Reproductive 4
- HDR Cap, Cervical 3
- MQG Accessory, Assisted Reproduction 2
- KNA Instrument, Manual, Specialized… 2
- HFE Brush, Endometrial 2
- MFD Cannula, Intrauterine Insemination 2
- GCJ Laparoscope, General & Plastic Surgery 2
- EZN Dilator, Catheter, Ureteral 1
- HDQ Dilator, Cervical, Fixed Size 1
- LKF Cannula, Manipulator/Injector, Uterine 1
- HAM Apparatus, Electrosurgical 1
- HIO Sampler, Amniotic Fluid (Amniocentesis Tray) 1
- JCX Apparatus, Suction, Ward Use, Portable… 1
- HHT Spatula, Cervical, Cytological 1
- HES Insufflator, Carbon-Dioxide, Uterotubal… 1
- GEJ Carrier, Ligature 1
- HHW Pessary, Vaginal 1
- HHM Sound, Uterine 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K062438 | Bakri Postpartum Balloon, Model J-SOS-100500KNA · Traditional | 10/27/2006SE |
| K030441 | Sydney Ivf Blastocyst Cryopreservation Kit and Sydney Ivf Blastocyst Thaw KitMQL · Traditional | 08/29/2003SE |
| K023850 | Sydney Ivf Embryo Biopsy MediumMQL · Traditional | 01/22/2003SE |
| K013597 | Tamponade Uterine Balloon Catheter SetKNA · Traditional | 04/17/2002SE |
| K002385 | Cook Ivf Follicle Flushing Buffer, Cook Ivf Oocyte Wash Buffer, Cook Ivf Fertilization…MQL · Traditional | 09/18/2000SE |
| K002383 | Cook Ivf Sperm Buffer, Cook Ivf Sperm Medium, and Cook Ivf Sperm Gradient KitMQL · Traditional | 09/13/2000SE |
| K983595 | Transmyometrial Embryo Transfer SetMQF · Traditional | 02/08/1999SE |
| K983596 | Intracytoplasmic Sperm Injection (Icsi) Micro-Injection Pipettes, Holding Pipettes…MQH · Traditional | 02/05/1999SE |
| K983642 | Cook Mini-IncubatorMQG · Traditional | 02/01/1999SE |
| K983593 | Ovum Pick-Up Aspiration NeedlesMQE · Traditional | 01/21/1999SE |
| K983594 | Embryo Transfer Catheters/SetsMQF · Traditional | 12/21/1998SE |
| K983591 | Intratubal Transfer SetsMQF · Traditional | 12/21/1998SE |
| K983590 | Gift Catheter Set/SMQF · Traditional | 12/21/1998SE |
| K983609 | Cook Test Tube HeaterMQG · Traditional | 12/16/1998SE |
| K983587 | Hysteroscopic Gift Catheter SetsMQF · Traditional | 12/16/1998SE |
| K931476 | Novy Cornual Cannulation SetMOV · Traditional | 07/28/1995SE |
| K941298 | Iumc Endometrial SamplerHFE · Traditional | 02/13/1995SE |
| K932114 | Tubal Lumen SupportHFJ · Traditional | 09/27/1994SE |
| K943970 | Disposable Laparoscopic Swab with Reusable HandleGCJ · Traditional | 09/06/1994SE |
| K911620 | Stovall Endometrial BrushHFE · Traditional | 06/24/1994SE |
| K931630 | Insemi-CathMFD · Traditional | 04/19/1994SE |
| K933415 | Detect (TM) Cytology BrushHHT · Traditional | 02/25/1994SE |
| K930900 | Cook Aspiration UnitJCX · Traditional | 07/22/1993SE |
| K914150 | Jansen-Anderson Insemination SetMFD · Traditional | 09/02/1992SE |
| K913300 | Laparostat(Tm)HAM · Traditional | 04/02/1992SE |
| K913299 | Sof-Flex Laparoscopic BasketHET · Traditional | 02/14/1992SE |
| K911887 | Majoli Uterine Manipulator/InjectorLKF · Traditional | 07/26/1991SE |
| K905471 | Trocar Access SheathHET · Traditional | 05/09/1991SE |
| K903187 | Laparoscopic CatherterHET · Traditional | 10/12/1990SE |
| K896701 | Teflon Cervical Access SetHDQ · Traditional | 09/13/1990SE |
| K896524 | Spirtos Coaxial Catheter SetHET · Traditional | 09/05/1990SE |
| K902694 | Coaxial Catheter SetHDR · Traditional | 08/28/1990SE |
| K896448 | Balloon Dilation CatheterEZN · Traditional | 03/07/1990SE |
| K897064 | Laparoscopic Access Sheath SetHET · Traditional | 02/06/1990SE |
| K894716 | Directable Coaxial Catheter SetGCJ · Traditional | 08/23/1989SE |
| K892846 | Echo-Tip Disposable Amniocentesis NeedleHIO · Traditional | 07/14/1989SE |
| K891290 | Sholkoff Balloon Hysterosalpingography CatheterHES · Traditional | 05/23/1989SE |
| K890301 | Shepard Intrauterine Insemination CatheterHDR · Traditional | 03/31/1989SE |
| K884553 | Stamey NeedleGEJ · Traditional | 11/14/1988SE |
| K883721 | Female Continence DeviceHHW · Traditional | 10/03/1988SE |
| K870550 | Teflon Uterine SoundHHM · Traditional | 03/04/1987SE |
| K870551 | Intrauterine Insemination CatheterHDR · Traditional | 03/02/1987SE |
| K852287 | Percutaneous Pigtail Suprapublic Catheter SetKOB · Traditional | 08/08/1985SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1416-2009 | Cook Medical Tao Brush I.U.M.C. Endometrial Cytology/Histology Sampler (Tao Brush)…There is an ink on the brush which has not been tested for use with the Tao Brush. | 04/02/2009Terminated |