HHW
- Product code
- HHW
- Device name
- Pessary, Vaginal
- Device class
- Class 2
- 21 CFR
- 21 CFR 884.3575
- Medical specialty
- Obstetrics/Gynecology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 7
- Summaries archived here
- 6 (direct download)
- 510(k) clearances (all years, FDA)
- 41 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (7)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253698 | 2026-01-20 | Cooper Surgical | Milex Incontinence Dish Pessaries; Milex Incontine | |
| K250438 | 2025-04-11 | CooperSurgical, Inc. | CooperSurgical Milex® Pessaries | |
| K240798 | 2024-12-17 | Cntrl+, Inc. | Cntrl+ Bladder Support Pessary | |
| K232677 | 2024-05-21 | Reia, LLC | Reia pessary | |
| K232525 | 2024-05-17 | Watkins-Conti Products, Inc. | Yoni.Fit Bladder Support | |
| K233548 | 2024-04-03 | Resilia, Inc. | Uresta® | FDA |
| K231786 | 2024-03-06 | Cosm Medical | Gynethotics Pessary |
Official FDA classification page: HHW
Classification and pathway per current FDA publications. Data from openFDA (CC0).