FDA Product Code
FDA Product Code HDX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.3900
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K241748 | Intimate Rose Vaginal Dilators | Plus EV Holdings Dba Intimate Rose | 2024-08-14 | Traditional | PDF ↗ |
| K233689 | Hope&Her Vaginal Dilators | Lujena, Inc. | 2024-05-02 | Traditional | PDF ↗ |
| K222492 | Hope&Her Vaginal Dilators | Lujena, Inc. | 2023-06-27 | Traditional | PDF ↗ |
| K231430 | Intimate Rose Vaginal Dilators | Plus EV Holdings Dba Intimate Rose | 2023-06-07 | Traditional | PDF ↗ |
| K220035 | Milli Vaginal Dilator | Materna Medical | 2023-02-27 | Traditional | PDF ↗ |
| K211959 | Milli Vaginal Dilator | Materna Medical | 2021-12-01 | Traditional | PDF ↗ |
| K130273 | PANPAC VAGINAL DILATORS | Panpac Medical Corporation | 2013-08-08 | Traditional | PDF ↗ |
| K071754 | NEO-VAGINA SURGERY SET AND ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | 2009-01-07 | Traditional | PDF ↗ |
| K003380 | BIOTEQUE VAGINAL DILATOR | Bioteque America, Inc. | 2001-01-29 | Traditional | PDF ↗ |
Product code HDX · Class II · Obstetrics/Gynecology. Data: openFDA.