QYZ
- Product code
- QYZ
- Device name
- At Home Intravaginal Insemination System
- Device class
- Class 2
- 21 CFR
- 21 CFR 884.6110
- Medical specialty
- Obstetrics/Gynecology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 3 (all years; only the last 3 years are listed here)
FDA classification definition
To deliver semen to the vaginal canal for insemination.
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K232579 | 2023-12-21 | Hannah Life Technologies Pte , Ltd. | Twoplus Applicator | — |
| K231645 | 2023-12-14 | Pherdal Fertility Science, Inc. | PherDal® At-Home Insemination Kit | |
| K231203 | 2023-11-29 | Mosie Baby | Mosie Baby Kit |
Official FDA classification page: QYZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).