Milli Vaginal Dilator
FDA 510(k) K211959 · Materna Medical
510(k) numberK211959
Submission
- Device name
- Milli Vaginal Dilator
- Applicant
- Materna Medical
Mountain View, CA, US - Received
- June 24, 2021
- Decision date
- December 1, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HDX – Dilator, Vaginal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.3900
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HDX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241748 | Intimate Rose Vaginal DilatorsHDX · Traditional | Plus EV Holdings Dba Intimate Rose | 08/14/2024SE |
| K233689 | Hope&Her Vaginal DilatorsHDX · Traditional | Lujena, Inc. | 05/02/2024SE |
| K222492 | Hope&Her Vaginal DilatorsHDX · Traditional | Lujena, Inc. | 06/27/2023SE |
| K231430 | Intimate Rose Vaginal DilatorsHDX · Traditional | Plus EV Holdings Dba Intimate Rose | 06/07/2023SE |
| K220035 | Milli Vaginal DilatorHDX · Traditional | Materna Medical | 02/27/2023SE |
| K130273 | Panpac Vaginal DilatorsHDX · Traditional | Panpac Medical Corporation | 08/08/2013SE |
| K071754 | Neo-Vagina Surgery Set and AccessoriesHDX · Traditional | KARL STORZ Endoscopy-America, Inc. | 01/07/2009SE |
| K003380 | Bioteque Vaginal DilatorHDX · Traditional | Bioteque America, Inc. | 01/29/2001SE |
More from Bioteque America, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K220035 | Milli Vaginal DilatorHDX · Traditional | 02/27/2023SE |
Questions and answers
When was Milli Vaginal Dilator cleared by the FDA?
Milli Vaginal Dilator (K211959) received a 510(k) decision of Substantially Equivalent on December 1, 2021, 160 days after the submission was received.
What is the product code of K211959?
The FDA product code is HDX – Dilator, Vaginal, a Class II (moderate risk) device regulated under 21 CFR 884.3900.