Cook Ob/Gyn
Spencer, IN, US
Cook Ob/Gyn appears in FDA device records in Spencer, IN. FDA records list 43 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 43 510(k) clearances for Cook Ob/Gyn between 1985 and 2006. The busiest year on record is 1990, with 6. The most recent is 2006, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1987 | 2 |
| 1988 | 2 |
| 1989 | 4 |
| 1990 | 6 |
| 1991 | 2 |
| 1992 | 3 |
| 1993 | 1 |
| 1994 | 5 |
| 1995 | 2 |
| 1998 | 5 |
| 1999 | 4 |
| 2000 | 2 |
| 2002 | 1 |
| 2003 | 2 |
| 2006 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K062438 | BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500 | KNA | Substantially Equivalent | |
| K030441 | SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT | MQL | Substantially Equivalent | |
| K023850 | SYDNEY IVF EMBRYO BIOPSY MEDIUM | MQL | Substantially Equivalent | |
| K013597 | TAMPONADE UTERINE BALLOON CATHETER SET | KNA | Substantially Equivalent | |
| K002385 | COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM, | MQL | Substantially Equivalent | |
| K002383 | COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT | MQL | Substantially Equivalent | |
| K983595 | TRANSMYOMETRIAL EMBRYO TRANSFER SET | MQF | Substantially Equivalent | |
| K983596 | INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING | MQH | Substantially Equivalent | |
| K983642 | COOK MINI-INCUBATOR | MQG | Substantially Equivalent | |
| K983593 | OVUM PICK-UP ASPIRATION NEEDLES | MQE | Substantially Equivalent | |
| K983594 | EMBRYO TRANSFER CATHETERS/SETS | MQF | Substantially Equivalent | |
| K983591 | INTRATUBAL TRANSFER SETS | MQF | Substantially Equivalent | |
| K983590 | GIFT CATHETER SET/S | MQF | Substantially Equivalent | |
| K983609 | COOK TEST TUBE HEATER | MQG | Substantially Equivalent | |
| K983587 | HYSTEROSCOPIC GIFT CATHETER SETS | MQF | Substantially Equivalent | |
| K931476 | NOVY CORNUAL CANNULATION SET | MOV | Substantially Equivalent | |
| K941298 | IUMC ENDOMETRIAL SAMPLER | HFE | Substantially Equivalent | |
| K932114 | TUBAL LUMEN SUPPORT | HFJ | Substantially Equivalent | |
| K943970 | DISPOSABLE LAPAROSCOPIC SWAB WITH REUSABLE HANDLE | GCJ | Substantially Equivalent | |
| K911620 | STOVALL ENDOMETRIAL BRUSH | HFE | Substantially Equivalent | |
| K931630 | INSEMI-CATH | MFD | Substantially Equivalent | |
| K933415 | DETECT (TM) CYTOLOGY BRUSH | HHT | Substantially Equivalent | |
| K930900 | COOK ASPIRATION UNIT | JCX | Substantially Equivalent | |
| K914150 | JANSEN-ANDERSON INSEMINATION SET | MFD | Substantially Equivalent | |
| K913300 | LAPAROSTAT(TM) | HAM | Substantially Equivalent | |
| K913299 | SOF-FLEX LAPAROSCOPIC BASKET | HET | Substantially Equivalent | |
| K911887 | MAJOLI UTERINE MANIPULATOR/INJECTOR | LKF | Substantially Equivalent | |
| K905471 | TROCAR ACCESS SHEATH | HET | Substantially Equivalent | |
| K903187 | LAPAROSCOPIC CATHERTER | HET | Substantially Equivalent | |
| K896701 | TEFLON CERVICAL ACCESS SET | HDQ | Substantially Equivalent | |
| K896524 | SPIRTOS COAXIAL CATHETER SET | HET | Substantially Equivalent | |
| K902694 | COAXIAL CATHETER SET | HDR | Substantially Equivalent | |
| K896448 | BALLOON DILATION CATHETER | EZN | Substantially Equivalent | |
| K897064 | LAPAROSCOPIC ACCESS SHEATH SET | HET | Substantially Equivalent | |
| K894716 | DIRECTABLE COAXIAL CATHETER SET | GCJ | Substantially Equivalent | |
| K892846 | ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE | HIO | Substantially Equivalent | |
| K891290 | SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER | HES | Substantially Equivalent | |
| K890301 | SHEPARD INTRAUTERINE INSEMINATION CATHETER | HDR | Substantially Equivalent | |
| K884553 | STAMEY NEEDLE | GEJ | Substantially Equivalent | |
| K883721 | FEMALE CONTINENCE DEVICE | HHW | Substantially Equivalent | |
| K870550 | TEFLON UTERINE SOUND | HHM | Substantially Equivalent | |
| K870551 | INTRAUTERINE INSEMINATION CATHETER | HDR | Substantially Equivalent | |
| K852287 | PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHETER SET | KOB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- MQGAccessory, Assisted Reproduction
- HAMApparatus, Electrosurgical
- JCXApparatus, Suction, Ward Use, Portable, Ac-Powered
- HFEBrush, Endometrial
- MFDCannula, Intrauterine Insemination
- LKFCannula, Manipulator/Injector, Uterine
- HDRCap, Cervical
- GEJCarrier, Ligature
- MQFCatheter, Assisted Reproduction
- KOBCatheter, Suprapubic (And Accessories)
- MOVCatheters, Salpingography
- EZNDilator, Catheter, Ureteral
- HDQDilator, Cervical, Fixed Size
- KNAInstrument, Manual, Specialized Obstetric-Gynecologic
- HESInsufflator, Carbon-Dioxide, Uterotubal (And Accessories)
- GCJLaparoscope, General & Plastic Surgery
- HETLaparoscope, Gynecologic (And Accessories)
- MQLMedia, Reproductive
- MQHMicrotools, Assisted Reproduction (Pipettes)
- MQENeedle, Assisted Reproduction
- HHWPessary, Vaginal
- HFJProsthesis, Fallopian Tube
- HIOSampler, Amniotic Fluid (Amniocentesis Tray)
- HHMSound, Uterine
- HHTSpatula, Cervical, Cytological
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1416-2009 | Cook Medical Tao Brush I.U.M.C. Endometrial Cytology/Histology Sampler (Tao Brush), 9.0Fr/26 cm, 3.5 cm, sterile, Cook Ob/Gyn, Spencer, IN; REF J-ES-090500-BL. Used to obtain endometrial samples for both cytology and histology. Intended for one-time use. | There is an ink on the brush which has not been tested for use with the Tao Brush. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain