HHW · Pessary, Vaginal
Obstetrics/Gynecology · 21 CFR 884.3575 · Class 2
Overview
| Product Code | HHW |
|---|---|
| Device Name | Pessary, Vaginal |
| Regulation | 21 CFR 884.3575 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 41)
Showing 20 most recent of 41 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253698 | Milex Incontinence Dish Pessaries; Milex Incontinence Dish Pessaries with Support; Milex Cube Pessaries; Milex Cube Pessaries with Drainage Holes | Cooper Surgical | Jan 20, 2026 | SESE |
| K250438 | CooperSurgical Milex® Pessaries | CooperSurgical, Inc. | Apr 11, 2025 | SESE |
| K240798 | Cntrl+ Bladder Support Pessary | Cntrl+, Inc. | Dec 17, 2024 | SESE |
| K232677 | Reia pessary | Reia, LLC | May 21, 2024 | SESE |
| K232525 | Yoni.Fit Bladder Support | Watkins-Conti Products, Inc. | May 17, 2024 | SESE |
| K233548 | Uresta® | Resilia, Inc. | Apr 3, 2024 | SESE |
| K231786 | Gynethotics Pessary | Cosm Medical | Mar 6, 2024 | SESE |
| K190277 | ProVate Vaginal Support | Contipi Medical , Ltd. | Jul 8, 2019 | SESE |
| K183468 | Revive Reusable Bladder Support | Rinovum Subsidiary 2, LLC | Jan 25, 2019 | SESE |
| K173351 | Panpac Flexi Shelf Pessary | Panpac Medical Corporation | Oct 31, 2018 | SESE |
| K153422 | Panpac Disposable Pessary Fitting Set | Panpac Medical Corporation | Jul 14, 2016 | SESE |
| K151413 | Always/Tampax bladder supports | Procter & Gamble | Dec 18, 2015 | SESE |
| K132313 | PESSARY | Eis Corporation | Dec 5, 2014 | SESE |
| K132670 | PANPAC INFLATABLE DOCUT PESSARY | Panpac Medical Corporation | Jun 4, 2014 | SESE |
| K131198 | TIPI OTC | Contipi , Ltd. | Aug 27, 2013 | SESE |
| K092981 | PANPAC VAGINAL PESSARY | Panpac Medical Corporation | Jul 22, 2010 | SESE |
| K083769 | MODIFICATION TO URESTA PESSARY | Eastmed, Inc. | Jan 14, 2009 | SESE |
| K081385 | URESTA PESSARY | Eastmed, Inc. | Oct 9, 2008 | SESE |
| K060526 | TIPI | Contipi , Ltd. | Jun 9, 2006 | SESE |
| K032644 | KOLPEXIN SPHERE | Adamed , Ltd. | May 28, 2004 | SESE |
Top Applicants
- Deschutes Medical Products, Inc. — 5 clearances
- Panpac Medical Corporation — 4 clearances
- Bioteque America, Inc. — 3 clearances
- Johnson & Johnson Medical, Inc. — 3 clearances
- Contipi , Ltd. — 2 clearances
