Company ยท US
Cook Ob/Gyn
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 2006. Name variants (Inc, Corp, punctuation) are merged.
43510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HET | Laparoscope, Gynecologic (And Accessories) | 5 |
| MQF | Catheter, Assisted Reproduction | 5 |
| MQL | Media, Reproductive | 4 |
| HDR | Cap, Cervical | 3 |
| HFE | Brush, Endometrial | 3 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 |
| KNA | Instrument, Manual, Specialized Obstetric-Gynecologic | 2 |
| MFD | Cannula, Intrauterine Insemination | 2 |
| MQG | Accessory, Assisted Reproduction | 2 |
| EZN | Dilator, Catheter, Ureteral | 1 |
| GEJ | Carrier, Ligature | 1 |
| HAM | Apparatus, Electrosurgical | 1 |
| HDQ | Dilator, Cervical, Fixed Size | 1 |
| HES | Insufflator, Carbon-Dioxide, Uterotubal (And Accessories) | 1 |
| HFJ | Prosthesis, Fallopian Tube | 1 |
| HHM | Sound, Uterine | 1 |
| HHT | Spatula, Cervical, Cytological | 1 |
| HHW | Pessary, Vaginal | 1 |
| HIO | Sampler, Amniotic Fluid (Amniocentesis Tray) | 1 |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 27, 2006 | K062438 | BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500 Cook Ob/Gyn | KNA |
| Aug 29, 2003 | K030441 | SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT Cook Ob/Gyn | MQL |
| Jan 22, 2003 | K023850 | SYDNEY IVF EMBRYO BIOPSY MEDIUM Cook Ob/Gyn | MQL |
| Apr 17, 2002 | K013597 | TAMPONADE UTERINE BALLOON CATHETER SET Cook Ob/Gyn | KNA |
| Sep 18, 2000 | K002385 | COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM, Cook Ob/Gyn | MQL |
| Sep 13, 2000 | K002383 | COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT Cook Ob/Gyn | MQL |
| Feb 8, 1999 | K983595 | TRANSMYOMETRIAL EMBRYO TRANSFER SET Cook Ob/Gyn | MQF |
| Feb 5, 1999 | K983596 | INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING Cook Ob/Gyn | MQH |
| Feb 1, 1999 | K983642 | COOK MINI-INCUBATOR Cook Ob/Gyn | MQG |
| Jan 21, 1999 | K983593 | OVUM PICK-UP ASPIRATION NEEDLES Cook Ob/Gyn | MQE |
| Dec 21, 1998 | K983594 | EMBRYO TRANSFER CATHETERS/SETS Cook Ob/Gyn | MQF |
| Dec 21, 1998 | K983591 | INTRATUBAL TRANSFER SETS Cook Ob/Gyn | MQF |
| Dec 21, 1998 | K983590 | GIFT CATHETER SET/S Cook Ob/Gyn | MQF |
| Dec 16, 1998 | K983609 | COOK TEST TUBE HEATER Cook Ob/Gyn | MQG |
| Dec 16, 1998 | K983587 | HYSTEROSCOPIC GIFT CATHETER SETS Cook Ob/Gyn | MQF |
| Jul 28, 1995 | K931476 | NOVY CORNUAL CANNULATION SET Cook Ob/Gyn | MOV |
| Feb 13, 1995 | K941298 | IUMC ENDOMETRIAL SAMPLER Cook Ob/Gyn | HFE |
| Sep 27, 1994 | K932114 | TUBAL LUMEN SUPPORT Cook Ob/Gyn | HFJ |
| Sep 6, 1994 | K943970 | DISPOSABLE LAPAROSCOPIC SWAB WITH REUSABLE HANDLE Cook Ob/Gyn | GCJ |
| Jun 24, 1994 | K911620 | STOVALL ENDOMETRIAL BRUSH Cook Ob/Gyn | HFE |
| Apr 19, 1994 | K931630 | INSEMI-CATH Cook Ob/Gyn | MFD |
| Feb 25, 1994 | K933415 | DETECT (TM) CYTOLOGY BRUSH Cook Ob/Gyn | HHT |
| Jul 22, 1993 | K930900 | COOK ASPIRATION UNIT Cook Ob/Gyn | JCX |
| Sep 2, 1992 | K914150 | JANSEN-ANDERSON INSEMINATION SET Cook Ob/Gyn | MFD |
| Apr 2, 1992 | K913300 | LAPAROSTAT(TM) Cook Ob/Gyn | HAM |
| Feb 14, 1992 | K913299 | SOF-FLEX LAPAROSCOPIC BASKET Cook Ob/Gyn | HET |
| Jul 26, 1991 | K911887 | MAJOLI UTERINE MANIPULATOR/INJECTOR Cook Ob/Gyn | LKF |
| May 9, 1991 | K905471 | TROCAR ACCESS SHEATH Cook Ob/Gyn | HET |
| Oct 12, 1990 | K903187 | LAPAROSCOPIC CATHERTER Cook Ob/Gyn | HET |
| Sep 13, 1990 | K896701 | TEFLON CERVICAL ACCESS SET Cook Ob/Gyn | HDQ |
| Sep 5, 1990 | K896524 | SPIRTOS COAXIAL CATHETER SET Cook Ob/Gyn | HET |
| Aug 28, 1990 | K902694 | COAXIAL CATHETER SET Cook Ob/Gyn | HDR |
| Mar 7, 1990 | K896448 | BALLOON DILATION CATHETER Cook Ob/Gyn | EZN |
| Feb 6, 1990 | K897064 | LAPAROSCOPIC ACCESS SHEATH SET Cook Ob/Gyn | HET |
| Aug 23, 1989 | K894716 | DIRECTABLE COAXIAL CATHETER SET Cook Ob/Gyn | GCJ |
| Jul 14, 1989 | K892846 | ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE Cook Ob/Gyn | HIO |
| May 23, 1989 | K891290 | SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER Cook Ob/Gyn | HES |
| Mar 31, 1989 | K890301 | SHEPARD INTRAUTERINE INSEMINATION CATHETER Cook Ob/Gyn | HDR |
| Nov 14, 1988 | K884553 | STAMEY NEEDLE Cook Ob/Gyn | GEJ |
| Oct 3, 1988 | K883721 | FEMALE CONTINENCE DEVICE Cook Ob/Gyn | HHW |
| Mar 4, 1987 | K870550 | TEFLON UTERINE SOUND Cook Ob/Gyn | HHM |
| Mar 2, 1987 | K870551 | INTRAUTERINE INSEMINATION CATHETER Cook Ob/Gyn | HDR |
| Aug 8, 1985 | K852287 | PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHETER SET Cook Ob/Gyn | KOB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 16, 2009 | Cook OB/Gyn, Inc. 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 Terminated |
HFE | K082066 K941298 |