Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

43 results for "Cook Ob/Gyn"
25–43 of 43
Search insights Median review: 87d Cleared: 100% Top manufacturer: Cook Ob/Gyn Lead specialty: Obstetrics & Gynecology
Cleared Apr 02, 1992
LAPAROSTAT(TM)
K913300 · HAM
Cook Ob/Gyn
General & Plastic Surgery · 252d
Cleared Feb 14, 1992
SOF-FLEX LAPAROSCOPIC BASKET
K913299 · HET
Cook Ob/Gyn
Obstetrics & Gynecology · 204d
Cleared Jul 26, 1991
MAJOLI UTERINE MANIPULATOR/INJECTOR
K911887 · LKF
Cook Ob/Gyn
Obstetrics & Gynecology · 88d
Cleared May 09, 1991
TROCAR ACCESS SHEATH
K905471 · HET
Cook Ob/Gyn
Obstetrics & Gynecology · 154d
Cleared Oct 12, 1990
LAPAROSCOPIC CATHERTER
K903187 · HET
Cook Ob/Gyn
Obstetrics & Gynecology · 85d
Cleared Sep 13, 1990
TEFLON CERVICAL ACCESS SET
K896701 · HDQ
Cook Ob/Gyn
Obstetrics & Gynecology · 289d
Cleared Sep 05, 1990
SPIRTOS COAXIAL CATHETER SET
K896524 · HET
Cook Ob/Gyn
Obstetrics & Gynecology · 294d
Cleared Aug 28, 1990
COAXIAL CATHETER SET
K902694 · HDR
Cook Ob/Gyn
Obstetrics & Gynecology · 70d
Cleared Mar 07, 1990
BALLOON DILATION CATHETER
K896448 · EZN
Cook Ob/Gyn
Gastroenterology & Urology · 118d
Cleared Feb 06, 1990
LAPAROSCOPIC ACCESS SHEATH SET
K897064 · HET
Cook Ob/Gyn
Obstetrics & Gynecology · 48d
Cleared Aug 23, 1989
DIRECTABLE COAXIAL CATHETER SET
K894716 · GCJ
Cook Ob/Gyn
General & Plastic Surgery · 29d
Cleared Jul 14, 1989
ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE
K892846 · HIO
Cook Ob/Gyn
Obstetrics & Gynecology · 87d
Cleared May 23, 1989
SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER
K891290 · HES
Cook Ob/Gyn
Obstetrics & Gynecology · 74d
Cleared Mar 31, 1989
SHEPARD INTRAUTERINE INSEMINATION CATHETER
K890301 · HDR
Cook Ob/Gyn
Obstetrics & Gynecology · 67d
Cleared Nov 14, 1988
STAMEY NEEDLE
K884553 · GEJ
Cook Ob/Gyn
General & Plastic Surgery · 14d
Cleared Oct 03, 1988
FEMALE CONTINENCE DEVICE
K883721 · HHW
Cook Ob/Gyn
Obstetrics & Gynecology · 33d
Cleared Mar 04, 1987
TEFLON UTERINE SOUND
K870550 · HHM
Cook Ob/Gyn
Obstetrics & Gynecology · 22d
Cleared Mar 02, 1987
INTRAUTERINE INSEMINATION CATHETER
K870551 · HDR
Cook Ob/Gyn
Obstetrics & Gynecology · 20d
Cleared Aug 08, 1985
PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHETER SET
K852287 · KOB
Cook Ob/Gyn
Gastroenterology & Urology · 71d