Milex Incontinence Dish Pessaries; Milex Incontinence Dish Pessaries with Support; Milex Cube Pessaries; Milex Cube Pessaries with Drainage Holes
FDA 510(k) K253698 · Cooper Surgical
510(k) numberK253698
Submission
- Device name
- Milex Incontinence Dish Pessaries; Milex Incontinence Dish Pessaries with Support; Milex Cube Pessaries; Milex Cube Pessaries with Drainage Holes
- Applicant
- Cooper Surgical
Trumbull, CT, US - Received
- November 24, 2025
- Decision date
- January 20, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HHW – Pessary, Vaginal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.3575
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HHW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250438 | CooperSurgical Milex® PessariesHHW · Traditional | CooperSurgical, Inc. | 04/11/2025SE |
| K240798 | Cntrl+ Bladder Support PessaryHHW · Traditional | Cntrl+, Inc. | 12/17/2024SE |
| K232677 | Reia pessaryHHW · Traditional | Reia, LLC | 05/21/2024SE |
| K232525 | Yoni.Fit Bladder SupportHHW · Traditional | Watkins-Conti Products, Inc. | 05/17/2024SE |
| K233548 | Uresta®HHW · Traditional | Resilia, Inc. | 04/03/2024SE |
| K231786 | Gynethotics PessaryHHW · Traditional | Cosm Medical | 03/06/2024SE |
| K190277 | ProVate Vaginal SupportHHW · Traditional | Contipi Medical , Ltd. | 07/08/2019SE |
| K183468 | Revive Reusable Bladder SupportHHW · Traditional | Rinovum Subsidiary 2, LLC | 01/25/2019SE |
| K173351 | Panpac Flexi Shelf PessaryHHW · Abbreviated | Panpac Medical Corporation | 10/31/2018SE |
| K153422 | Panpac Disposable Pessary Fitting SetHHW · Special | Panpac Medical Corporation | 07/14/2016SE |
More from Panpac Medical Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K091325 | Ten-Year Fracture Risk Option and Siri Table Option for Norland Dxa Bone DensitometersKGI · Traditional | 06/29/2009SE |
| K023382 | Coopersurgical Malleable SytletMQF · Traditional | 12/20/2002SE |
| K023384 | Coopersurgical Trial Transfer CatheterMQF · Traditional | 12/13/2002SE |
| K023383 | Coopersurgical Intrauterine Insemination CatheterMQF · Traditional | 12/13/2002SE |
| K023379 | Coopersurgical Embryo Transfer Catheter, Coopersurgical Assisted Reproduction CatheterMQF · Traditional | 12/11/2002SE |
Questions and answers
When was Milex Incontinence Dish Pessaries; Milex Incontinence Dish Pessaries with Support; Milex Cube Pessaries; Milex Cube Pessaries with Drainage Holes cleared by the FDA?
Milex Incontinence Dish Pessaries; Milex Incontinence Dish Pessaries with Support; Milex Cube Pessaries; Milex Cube Pessaries with Drainage Holes (K253698) received a 510(k) decision of Substantially Equivalent on January 20, 2026, 57 days after the submission was received.
What is the product code of K253698?
The FDA product code is HHW – Pessary, Vaginal, a Class II (moderate risk) device regulated under 21 CFR 884.3575.