HEW · Class II · 21 CFR 884.1640

FDA Product Code HEW: Culdoscope (and Accessories)

Leading manufacturers include CooperSurgical, Inc., Applied Medical Resources Corp. and KARL STORZ Endoscopy-America, Inc..

18
Total
18
Cleared
196d
Avg days
1996
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 367d recently vs 186d historically

FDA 510(k) Cleared Culdoscope (and Accessories) Devices (Product Code HEW)

18 devices
1–18 of 18
Cleared Oct 02, 2025
GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device
K243152
Applied Medical Resources Corp.
Obstetrics & Gynecology · 367d
Cleared May 21, 2020
Advincula Delineator Uterine Manipulator
K201086
CooperSurgical, Inc.
Obstetrics & Gynecology · 28d
Cleared Sep 06, 2019
Transvaginal Access Platform
K191294
Applied Medical Resources Corp.
Obstetrics & Gynecology · 115d
Cleared Mar 14, 2018
Advincula Delineator Uterine Manipulator
K180429
CooperSurgical, Inc.
Obstetrics & Gynecology · 26d
Cleared Oct 27, 2016
ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator
K161065
Surgitools Pty , Ltd.
Obstetrics & Gynecology · 195d
Cleared Oct 13, 2015
GelPOINT Transvaginal Access Platform
K143308
Applied Medical Resources
Obstetrics & Gynecology · 329d
Cleared Jul 21, 2015
CooperSurgical Advincula Delineator Uterine Manipulator
K143650
CooperSurgical, Inc.
Obstetrics & Gynecology · 210d
Cleared Jul 13, 2012
LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES
K111014
Lsi Solutions, Inc.
Obstetrics & Gynecology · 459d
Cleared Oct 05, 2011
SINGHMED ROOLIP MANIPULATOR
K110819
J.Singh Instruments
Obstetrics & Gynecology · 196d
Cleared Sep 02, 2005
MANIPUSEAL
K051160
Insitu Systems
Obstetrics & Gynecology · 120d
Cleared Sep 02, 2005
MCCARTNEY ACCESS TUBE
K051594
Gynetech Pty. , Ltd.
Obstetrics & Gynecology · 78d
Cleared Feb 27, 2004
TRANSVAGINAL ENDOSCOPY SET
K033728
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 91d
Cleared Mar 13, 2000
FERTILOSCOPY KIT FH 1.29/FTO 1.40
K992655
Soprane S.A.
Obstetrics & Gynecology · 217d
Cleared Feb 07, 2000
KSEA RIGID CULDOSCOPE AND ACCESSORIES
K993804
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 90d
Cleared Jun 12, 1998
RIGID CULDOSCOPE AND ACCESSORIES
K980972
Circon Corp.
Obstetrics & Gynecology · 88d
Cleared Nov 25, 1997
ENDOSCOPIC HYSTERECTOMY AND UTERUS MANIPULATOR
K964276
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 393d
Cleared Nov 19, 1996
KOH COLPOTOMIZER SYSTEM
K954311
CooperSurgical, Inc.
Obstetrics & Gynecology · 431d
Cleared Oct 22, 1996
KSEA CULDOCENTESIS SET
K962881
Karl Storz Endoscopy
Obstetrics & Gynecology · 90d

About Product Code HEW - Regulatory Context

510(k) Submission Activity

18 total 510(k) submissions under product code HEW since 1996, with 18 receiving FDA clearance (average review time: 196 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - HEW Product Code

Recent submissions under HEW have taken an average of 367 days to reach a decision - up from 186 days historically. Manufacturers should account for longer review timelines in current project planning.

HEW devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →