Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Cook Ob/Gyn — Predicate Candidate Screening

43 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

87 daysmedian FDA review time

352 days90th percentile

43clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K062438	BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500	Cook Ob/Gyn	2006-10-27	67	0
K030441	SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BL	Cook Ob/Gyn	2003-08-29	199	0
K023850	SYDNEY IVF EMBRYO BIOPSY MEDIUM	Cook Ob/Gyn	2003-01-22	64	0
K013597	TAMPONADE UTERINE BALLOON CATHETER SET	Cook Ob/Gyn	2002-04-17	168	0
K002385	COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFF	Cook Ob/Gyn	2000-09-18	45	0
K002383	COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF S	Cook Ob/Gyn	2000-09-13	40	0
K983595	TRANSMYOMETRIAL EMBRYO TRANSFER SET	Cook Ob/Gyn	1999-02-08	118	0
K983596	INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPE	Cook Ob/Gyn	1999-02-05	115	3
K983642	COOK MINI-INCUBATOR	Cook Ob/Gyn	1999-02-01	108	2
K983593	OVUM PICK-UP ASPIRATION NEEDLES	Cook Ob/Gyn	1999-01-21	100	0
K983594	EMBRYO TRANSFER CATHETERS/SETS	Cook Ob/Gyn	1998-12-21	69	0
K983591	INTRATUBAL TRANSFER SETS	Cook Ob/Gyn	1998-12-21	69	0
K983590	GIFT CATHETER SET/S	Cook Ob/Gyn	1998-12-21	69	0
K983609	COOK TEST TUBE HEATER	Cook Ob/Gyn	1998-12-16	63	0
K983587	HYSTEROSCOPIC GIFT CATHETER SETS	Cook Ob/Gyn	1998-12-16	64	0
K931476	NOVY CORNUAL CANNULATION SET	Cook Ob/Gyn	1995-07-28	856	3
K941298	IUMC ENDOMETRIAL SAMPLER	Cook Ob/Gyn	1995-02-13	333	1
K932114	TUBAL LUMEN SUPPORT	Cook Ob/Gyn	1994-09-27	512	0
K943970	DISPOSABLE LAPAROSCOPIC SWAB WITH REUSABLE HANDLE	Cook Ob/Gyn	1994-09-06	22	0
K911620	STOVALL ENDOMETRIAL BRUSH	Cook Ob/Gyn	1994-06-24	1170	0
K931630	INSEMI-CATH	Cook Ob/Gyn	1994-04-19	382	0
K933415	DETECT (TM) CYTOLOGY BRUSH	Cook Ob/Gyn	1994-02-25	227	0
K930900	COOK ASPIRATION UNIT	Cook Ob/Gyn	1993-07-22	150	0
K914150	JANSEN-ANDERSON INSEMINATION SET	Cook Ob/Gyn	1992-09-02	352	0
K913300	LAPAROSTAT(TM)	Cook Ob/Gyn	1992-04-02	252	0
K913299	SOF-FLEX LAPAROSCOPIC BASKET	Cook Ob/Gyn	1992-02-14	204	0
K911887	MAJOLI UTERINE MANIPULATOR/INJECTOR	Cook Ob/Gyn	1991-07-26	88	0
K905471	TROCAR ACCESS SHEATH	Cook Ob/Gyn	1991-05-09	154	0
K903187	LAPAROSCOPIC CATHERTER	Cook Ob/Gyn	1990-10-12	85	0
K896701	TEFLON CERVICAL ACCESS SET	Cook Ob/Gyn	1990-09-13	289	0
K896524	SPIRTOS COAXIAL CATHETER SET	Cook Ob/Gyn	1990-09-05	294	0
K902694	COAXIAL CATHETER SET	Cook Ob/Gyn	1990-08-28	70	0
K896448	BALLOON DILATION CATHETER	Cook Ob/Gyn	1990-03-07	118	0
K897064	LAPAROSCOPIC ACCESS SHEATH SET	Cook Ob/Gyn	1990-02-06	48	0
K894716	DIRECTABLE COAXIAL CATHETER SET	Cook Ob/Gyn	1989-08-23	29	0
K892846	ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE	Cook Ob/Gyn	1989-07-14	87	0
K891290	SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER	Cook Ob/Gyn	1989-05-23	74	0
K890301	SHEPARD INTRAUTERINE INSEMINATION CATHETER	Cook Ob/Gyn	1989-03-31	67	0
K884553	STAMEY NEEDLE	Cook Ob/Gyn	1988-11-14	14	0
K883721	FEMALE CONTINENCE DEVICE	Cook Ob/Gyn	1988-10-03	33	0
K870550	TEFLON UTERINE SOUND	Cook Ob/Gyn	1987-03-04	22	0
K870551	INTRAUTERINE INSEMINATION CATHETER	Cook Ob/Gyn	1987-03-02	20	0
K852287	PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHETER SET	Cook Ob/Gyn	1985-08-08	71	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda