ProVate Vaginal Support
FDA 510(k) K190277 · Contipi Medical , Ltd.
510(k) numberK190277
Submission
- Device name
- ProVate Vaginal Support
- Applicant
- Contipi Medical , Ltd.
Caesarea, IL - Received
- February 8, 2019
- Decision date
- July 8, 2019
- 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 |
|---|---|---|---|
| K253698 | Milex Incontinence Dish Pessaries; Milex Incontinence Dish Pessaries with Support…HHW · Traditional | Cooper Surgical | 01/20/2026SE |
| 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 |
| 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 |
Questions and answers
When was ProVate Vaginal Support cleared by the FDA?
ProVate Vaginal Support (K190277) received a 510(k) decision of Substantially Equivalent on July 8, 2019, 150 days after the submission was received.
What is the product code of K190277?
The FDA product code is HHW – Pessary, Vaginal, a Class II (moderate risk) device regulated under 21 CFR 884.3575.