QYZ
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- At Home Intravaginal Insemination System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.6110
- Medical specialty
- Obstetrics/Gynecology
- FDA definition
- To deliver semen to the vaginal canal for insemination.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Twoplus Applicator (K232579) | Hannah Life Technologies Pte , Ltd. | 2023-12-21 |
| PherDal® At-Home Insemination Kit (K231645) | Pherdal Fertility Science, Inc. | 2023-12-14 |
| Mosie Baby Kit (K231203) | Mosie Baby | 2023-11-29 |
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Every clearance here is in the API, with alerts when new ones post.