Product code QYZ
- Device name
- At Home Intravaginal Insemination System
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.6110
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- To deliver semen to the vaginal canal for insemination.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| K232579 | Twoplus Applicator | Hannah Life Technologies Pte , Ltd. | 2023-12-21 |
| K231645 | PherDal® At-Home Insemination Kit | Pherdal Fertility Science, Inc. | 2023-12-14 |
| K231203 | Mosie Baby Kit | Mosie Baby | 2023-11-29 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 08881300389024 | twoplus Applicator | HANNAH LIFE TECHNOLOGIES PTE. LTD. | 2024-02-06 |