FDA 510(k) Applications for Medical Device Product Code: HEW (Culdoscope (And Accessories))

FDA 510(k) Applications for Medical Device Product Code "HEW"
(Culdoscope (And Accessories))

FDA 510(k) Number	Applicant	Device Name	Decision Date
K143308	APPLIED MEDICAL RESOURCES	GelPOINT Transvaginal Access Platform	10/13/2015
K191294	Applied Medical Resources Corp.	Transvaginal Access Platform	09/06/2019
K980972	CIRCON CORP.	RIGID CULDOSCOPE AND ACCESSORIES	06/12/1998
K143650	Cooper Surgical Inc.	CooperSurgical Advincula Delineator Uterine Manipulator	07/21/2015
K180429	CooperSurgical, Inc.	Advincula Delineator Uterine Manipulator	03/14/2018
K201086	CooperSurgical, Inc.	Advincula Delineator Uterine Manipulator	05/21/2020
K954311	COOPERSURGICAL, INC.	KOH COLPOTOMIZER SYSTEM	11/19/1996
K051594	GYNETECH PTY. LTD.	MCCARTNEY ACCESS TUBE	09/02/2005
K051160	INSITU SYSTEMS	MANIPUSEAL	09/02/2005
K110819	J.SINGH INSTRUMENTS	SINGHMED ROOLIP MANIPULATOR	10/05/2011
K962881	KARL STORZ ENDOSCOPY	KSEA CULDOCENTESIS SET	10/22/1996
K993804	KARL STORZ ENDOSCOPY-AMERICA, INC.	KSEA RIGID CULDOSCOPE AND ACCESSORIES	02/07/2000
K033728	KARL STORZ ENDOSCOPY-AMERICA, INC.	TRANSVAGINAL ENDOSCOPY SET	02/27/2004
K111014	LSI SOLUTIONS, INC.	LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES	07/13/2012
K964276	RICHARD WOLF MEDICAL INSTRUMENTS CORP.	ENDOSCOPIC HYSTERECTOMY AND UTERUS MANIPULATOR	11/25/1997
K992655	SOPRANE S.A.	FERTILOSCOPY KIT FH 1.29/FTO 1.40	03/13/2000
K161065	Surgitools Pty Ltd.	ColpoWaveÖ Colpotomizer and CerviGripÖ Uterine Manipulator	10/27/2016