FDA 510(k) Applications for Medical Device Product Code: KNA (Instrument, Manual, Specialized Obstetric-Gynecologic)

FDA 510(k) Applications for Medical Device Product Code "KNA"
(Instrument, Manual, Specialized Obstetric-Gynecologic)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K062438	COOK OB/GYN	BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500	10/27/2006
K013597	COOK OB/GYN	TAMPONADE UTERINE BALLOON CATHETER SET	04/17/2002
K952527	COOK UROLOGICAL, INC.	BALLOON UTERINE STENT	01/02/1996
K082939	COOK UROLOGICAL, INC.	COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400	09/03/2009
K102141	COOK UROLOGICAL, INC.	COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)	05/06/2011
K060289	FRONTLINE MEDICAL	EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01	07/07/2006
K093904	GLENVEIGH SURGICAL, LLC	GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER	04/14/2010
K980237	GYNEX CORP.	GYNEX ENDOSPECULUM	04/08/1998
K990738	M.S. JAHANGER, MD	DR. JAHANGER'S CUTTER	10/29/1999
K972013	NATIONAL HEALTHCARE MFG. CORP.	NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PACKS	08/26/1997
K130087	Panpac Medical Corporation	PANPAC WORD/BARTHOLIN CATHETER	01/10/2014
K990045	POAMAX L.L.C.	BERACLAMP, MODEL BC-1	05/24/1999
K971277	TALON MEDICAL, LTD.	SAFE-T-CLAMP	05/20/1997
K001590	UROGYN LTD.	DND 101	08/02/2000
K014248	UROGYN LTD.	DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER	03/21/2002
K980717	UROMED CORP.	UROMED SLING KIT	05/22/1998
K982464	WOMEN FIRST HEALTHCARE, INC.	SCC-23 SAFETY CLAMP AND CUTTER	08/11/1998