FDA Product Code HDX: Dilator, Vaginal
Leading manufacturers include Lujena, Inc., Plus EV Holdings Dba Intimate Rose and Materna Medical.
9
Total
9
Cleared
219d
Avg days
2001
Since
Declining activity -
0 submissions in the last 2 years
vs 5 in the prior period
FDA 510(k) Cleared Dilator, Vaginal Devices (Product Code HDX)
9 devices
Cleared
Aug 14, 2024
Intimate Rose Vaginal Dilators
Plus EV Holdings Dba Intimate Rose
Obstetrics & Gynecology
57d
Cleared
May 02, 2024
Hope&Her Vaginal Dilators
Lujena, Inc.
Obstetrics & Gynecology
167d
Cleared
Jun 27, 2023
Hope&Her Vaginal Dilators
Lujena, Inc.
Obstetrics & Gynecology
314d
Cleared
Jun 07, 2023
Intimate Rose Vaginal Dilators
Plus EV Holdings Dba Intimate Rose
Obstetrics & Gynecology
21d
Cleared
Feb 27, 2023
Milli Vaginal Dilator
Materna Medical
Obstetrics & Gynecology
418d
Cleared
Dec 01, 2021
Milli Vaginal Dilator
Materna Medical
Obstetrics & Gynecology
160d
Cleared
Aug 08, 2013
PANPAC VAGINAL DILATORS
Panpac Medical Corporation
Obstetrics & Gynecology
185d
Cleared
Jan 07, 2009
NEO-VAGINA SURGERY SET AND ACCESSORIES
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology
559d
Cleared
Jan 29, 2001
BIOTEQUE VAGINAL DILATOR
Bioteque America, Inc.
Obstetrics & Gynecology
90d
About Product Code HDX - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code HDX since 2001, with 9 receiving FDA clearance (average review time: 219 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 5 in the prior period.