At Home Intravaginal Insemination System
The at-home intravaginal insemination system (product code QYZ) is a Class 2 Obstetrics/Gynecology device (regulation 884.6110) intended to deliver semen to the vaginal canal for insemination in a home setting. It requires 510(k) clearance. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QYZ
- Device Class
- FDA class 2
- Regulation Number
- 884.6110
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
Definition
To deliver semen to the vaginal canal for insemination.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K232579 | Twoplus Applicator | Dec 21, 2023 | Substantially Equivalent | Hannah Life Technologies Pte , Ltd. |
| K231645 | PherDal® At-Home Insemination Kit | Dec 14, 2023 | Substantially Equivalent | Pherdal Fertility Science, Inc. |
| K231203 | Mosie Baby Kit | Nov 29, 2023 | Substantially Equivalent | Mosie Baby |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.