FDA Product Code HEW: Culdoscope (and Accessories)
Leading manufacturers include KARL STORZ Endoscopy-America, Inc., CooperSurgical, Inc. and Applied Medical Resources Corp..
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
Cleared
Oct 02, 2025
GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device
Applied Medical Resources Corp.
Obstetrics & Gynecology
367d
Cleared
May 21, 2020
Advincula Delineator Uterine Manipulator
CooperSurgical, Inc.
Obstetrics & Gynecology
28d
Cleared
Sep 06, 2019
Transvaginal Access Platform
Applied Medical Resources Corp.
Obstetrics & Gynecology
115d
Cleared
Mar 14, 2018
Advincula Delineator Uterine Manipulator
CooperSurgical, Inc.
Obstetrics & Gynecology
26d
Cleared
Feb 27, 2004
TRANSVAGINAL ENDOSCOPY SET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology
91d
Cleared
Feb 07, 2000
KSEA RIGID CULDOSCOPE AND ACCESSORIES
KARL STORZ Endoscopy-America, Inc.
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 →