510(k) K071754
- Device
- NEO-VAGINA SURGERY SET AND ACCESSORIES
- Applicant
- KARL STORZ ENDOSCOPY-AMERICA, INC.
- 510(k) number
- K071754
- Product code
- HDX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-01-07
- Date received
- 2007-06-28
- 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
- No
Applicant Contact#
- Contact
- CRYSTAL DIZOL
- Address
- 600 Corporate Pt.e Culver City CA US 90230 90230
FDA Registration Numbers#
- 3010000450
- 3010131137
- 2020550
- 3011630465
- 3011137372
- 3013557562
- 3010202439
- 3003968049
- 3010041511
- 3003418325
- 3038319740
- 3014485094
- 3007137643
- 3029582858
- 1450908
- 3015895045
- 3024860690
- 2431166
- 3009513193
Source Documents#
Other 510(k) Records For Product Code HDX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241748 | Intimate Rose Vaginal Dilators | Plus EV Holdings Dba Intimate Rose | 2024-08-14 |
| 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 |
| K003380 | BIOTEQUE VAGINAL DILATOR | Bioteque America, Inc. | 2001-01-29 |
Legacy Summary#
summary
FDA Review#
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