HEW — Culdoscope (And Accessories) Class II

FDA Device Classification

Classification Details

Product Code
HEW
Device Class
Class II
Regulation Number
884.1640
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243152applied medical resourcesGelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceOctober 2, 2025
K201086coopersurgicalAdvincula Delineator Uterine ManipulatorMay 21, 2020
K191294applied medical resourcesTransvaginal Access PlatformSeptember 6, 2019
K180429coopersurgicalAdvincula Delineator Uterine ManipulatorMarch 14, 2018
K161065surgitools ptyColpoWave™ Colpotomizer and CerviGrip™ Uterine ManipulatorOctober 27, 2016
K143308applied medical resourcesGelPOINT Transvaginal Access PlatformOctober 13, 2015
K143650coopersurgicalCooperSurgical Advincula Delineator Uterine ManipulatorJuly 21, 2015
K111014lsi solutionsLSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIESJuly 13, 2012
K110819j.singh instrumentsSINGHMED ROOLIP MANIPULATOROctober 5, 2011
K051160insitu systemsMANIPUSEALSeptember 2, 2005
K051594gynetech pty.MCCARTNEY ACCESS TUBESeptember 2, 2005
K033728karl storz endoscopy-americaTRANSVAGINAL ENDOSCOPY SETFebruary 27, 2004
K992655sopraneFERTILOSCOPY KIT FH 1.29/FTO 1.40March 13, 2000
K993804karl storz endoscopy-americaKSEA RIGID CULDOSCOPE AND ACCESSORIESFebruary 7, 2000
K980972circonRIGID CULDOSCOPE AND ACCESSORIESJune 12, 1998
K964276richard wolf medical instrumentsENDOSCOPIC HYSTERECTOMY AND UTERUS MANIPULATORNovember 25, 1997
K954311coopersurgicalKOH COLPOTOMIZER SYSTEMNovember 19, 1996
K962881karl storz endoscopyKSEA CULDOCENTESIS SETOctober 22, 1996