510(k) K241748
- Device
- Intimate Rose Vaginal Dilators
- Applicant
- Plus EV Holdings Dba Intimate Rose
- 510(k) number
- K241748
- Product code
- HDX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-08-14
- Date received
- 2024-06-18
- Regulation
- 884.3900
- Classification name
- Dilator, Vaginal
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- Aaron Wilt
- Address
- 1419 Murray St. North Kansas City MO US 64116 64116
FDA Registration Numbers#
- 3014485094
- 3038319740
- 1450908
- 3003418325
- 3003968049
- 3029582858
- 2431166
- 3007137643
- 3010000450
- 3024860690
- 3011630465
- 3010202439
- 2020550
- 3015895045
- 3010131137
- 3009513193
- 3011137372
- 3013557562
- 3010041511
Source Documents#
Other 510(k) Records For Product Code HDX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233689 | Hope&Her Vaginal Dilators | Lujena, Inc. | 2024-05-02 |
| K222492 | Hope&Her Vaginal Dilators | Lujena, Inc. | 2023-06-27 |
| K231430 | Intimate Rose Vaginal Dilators | Plus EV Holdings Dba Intimate Rose | 2023-06-07 |
| K220035 | Milli Vaginal Dilator | Materna Medical | 2023-02-27 |
| K211959 | Milli Vaginal Dilator | Materna Medical | 2021-12-01 |
| K130273 | PANPAC VAGINAL DILATORS | Panpac Medical Corporation | 2013-08-08 |
| K071754 | NEO-VAGINA SURGERY SET AND ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | 2009-01-07 |
| K003380 | BIOTEQUE VAGINAL DILATOR | Bioteque America, Inc. | 2001-01-29 |