Product code KXP
- Device name
- Stent, Vaginal
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.3900
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00650551002932 | ALLURA® | PMT CORPORATION | 2025-03-19 |
| 00650551003229 | ALLURA® | PMT CORPORATION | 2025-03-19 |
| 00650551003236 | ALLURA® | PMT CORPORATION | 2025-03-19 |
| 00650551003458 | ALLURA® | PMT CORPORATION | 2025-03-19 |
| 00650551005148 | ALLURA® | PMT CORPORATION | 2025-03-19 |
| 00650551147619 | ALLURA® | PMT CORPORATION | 2025-03-19 |
| 00650551002758 | ALLURA | PMT CORPORATION | 2021-10-27 |
| 00650551002666 | ALLURA | PMT CORPORATION | 2021-09-20 |
| 00650551002284 | ALLURA | PMT CORPORATION | 2021-09-20 |
| 00650551002277 | ALLURA | PMT CORPORATION | 2021-09-20 |
| 00650551002260 | ALLURA | PMT CORPORATION | 2021-09-20 |
| 00650551002246 | ALLURA | PMT CORPORATION | 2021-09-20 |
| 00650551002239 | ALLURA | PMT CORPORATION | 2021-09-20 |
| 00650551002222 | ALLURA | PMT CORPORATION | 2021-09-20 |
| 00650551002253 | ALLURA | PMT CORPORATION | 2021-09-20 |
| 00384702174017 | Amielle | OWEN MUMFORD LIMITED | 2016-09-22 |
| 00384702173010 | Amielle | OWEN MUMFORD LIMITED | 2016-09-22 |
| 00384702172013 | Amielle | OWEN MUMFORD LIMITED | 2016-09-22 |
| 00384702171016 | Amielle | OWEN MUMFORD LIMITED | 2016-09-22 |
| 00384702100030 | Amielle | OWEN MUMFORD USA INCORPORATED | 2016-09-19 |
| 00384702101013 | Amielle | OWEN MUMFORD USA INCORPORATED | 2016-09-19 |
| 00384702102010 | Amielle | OWEN MUMFORD USA INCORPORATED | 2016-09-19 |
| 00384702103017 | Amielle | OWEN MUMFORD USA INCORPORATED | 2016-09-19 |
| 00384702104014 | Amielle | OWEN MUMFORD USA INCORPORATED | 2016-09-19 |
| 00384702105011 | Amielle | OWEN MUMFORD USA INCORPORATED | 2016-09-19 |
| 00384702100016 | Amielle | OWEN MUMFORD USA INCORPORATED | 2016-09-19 |
| 00812790024940 | SIENTRA Vaginal Stent | Sientra, Inc. | 2015-10-23 |
| 00812790024933 | SIENTRA Vaginal Stent | Sientra, Inc. | 2015-10-23 |
| 00812790024926 | SIENTRA Vaginal Stent | Sientra, Inc. | 2015-10-23 |
| 00812790024919 | SIENTRA Vaginal Stent | Sientra, Inc. | 2015-10-23 |