FDA Product Code HHW: Pessary, Vaginal
Leading manufacturers include Panpac Medical Corporation, Rinovum Subsidiary 2, LLC and Contipi Medical , Ltd..
41
Total
41
Cleared
205d
Avg days
1977
Since
Declining activity -
3 submissions in the last 2 years
vs 4 in the prior period
Review times improving: avg
128d
recently vs 217d historically
FDA 510(k) Cleared Pessary, Vaginal Devices (Product Code HHW)
41 devices
Cleared
Jan 20, 2026
Milex™ Incontinence Dish Pessaries
Cooper Surgical
Obstetrics & Gynecology
57d
Cleared
Apr 11, 2025
CooperSurgical Milex® Pessaries
CooperSurgical, Inc.
Obstetrics & Gynecology
56d
Cleared
Dec 17, 2024
Cntrl+ Bladder Support Pessary
Cntrl+, Inc.
Gastroenterology & Urology
270d
Cleared
May 21, 2024
Reia pessary
Reia, LLC
Obstetrics & Gynecology
263d
Cleared
May 17, 2024
Yoni.Fit Bladder Support
Watkins-Conti Products, Inc.
Gastroenterology & Urology
270d
Cleared
Apr 03, 2024
Uresta®
Resilia, Inc.
Gastroenterology & Urology
152d
Cleared
Mar 06, 2024
Gynethotics™ Pessary
Cosm Medical
Obstetrics & Gynecology
260d
Cleared
Jul 08, 2019
ProVate Vaginal Support
Contipi Medical , Ltd.
Obstetrics & Gynecology
150d
Cleared
Jan 25, 2019
Revive Reusable Bladder Support
Rinovum Subsidiary 2, LLC
Gastroenterology & Urology
42d
Cleared
Oct 31, 2018
Panpac Flexi Shelf Pessary
Panpac Medical Corporation
Obstetrics & Gynecology
371d
About Product Code HHW - Regulatory Context
510(k) Submission Activity
41 total 510(k) submissions under product code HHW since 1977, with 41 receiving FDA clearance (average review time: 205 days).
Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 4 in the prior period.
FDA 510(k) Review Time - HHW Product Code
Recent submissions under HHW have taken an average of 128 days to reach a decision - down from 217 days historically, suggesting improved FDA processing for this classification.
HHW devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →