HHW · Class II · 21 CFR 884.3575

FDA Product Code HHW: Pessary, Vaginal

Leading manufacturers include Johnson & Johnson Medical, Inc., Panpac Medical Corporation and Rinovum Subsidiary 2, LLC.

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
1–24 of 41
Cleared Jan 20, 2026
Milex™ Incontinence Dish Pessaries
K253698
Cooper Surgical
Obstetrics & Gynecology · 57d
Cleared Apr 11, 2025
CooperSurgical Milex® Pessaries
K250438
CooperSurgical, Inc.
Obstetrics & Gynecology · 56d
Cleared Dec 17, 2024
Cntrl+ Bladder Support Pessary
K240798
Cntrl+, Inc.
Gastroenterology & Urology · 270d
Cleared May 21, 2024
Reia pessary
K232677
Reia, LLC
Obstetrics & Gynecology · 263d
Cleared May 17, 2024
Yoni.Fit Bladder Support
K232525
Watkins-Conti Products, Inc.
Gastroenterology & Urology · 270d
Cleared Apr 03, 2024
Uresta®
K233548
Resilia, Inc.
Gastroenterology & Urology · 152d
Cleared Mar 06, 2024
Gynethotics™ Pessary
K231786
Cosm Medical
Obstetrics & Gynecology · 260d
Cleared Jul 08, 2019
ProVate Vaginal Support
K190277
Contipi Medical , Ltd.
Obstetrics & Gynecology · 150d
Cleared Jan 25, 2019
Revive Reusable Bladder Support
K183468
Rinovum Subsidiary 2, LLC
Gastroenterology & Urology · 42d
Cleared Oct 31, 2018
Panpac Flexi Shelf Pessary
K173351
Panpac Medical Corporation
Obstetrics & Gynecology · 371d
Cleared Dec 13, 1999
MENTOR EVACARE VAGINAL PESSARIES
K993308
Mentor Corp.
Obstetrics & Gynecology · 70d
Cleared Mar 10, 1997
INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL
K965040
Johnson & Johnson Medical, Inc.
Obstetrics & Gynecology · 83d
Cleared May 04, 1995
VAGINAL CONTINENCE DEVICE
K930618
Johnson & Johnson Medical, Inc.
Obstetrics & Gynecology · 815d
Cleared May 04, 1995
BLADDER NECK SUPPORT PROTHESIS FITTING KIT
K933654
Johnson & Johnson Medical, Inc.
Obstetrics & Gynecology · 646d
Cleared Oct 03, 1988
FEMALE CONTINENCE DEVICE
K883721
Cook Ob/Gyn
Obstetrics & Gynecology · 33d

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 →