510(k) K231645
K231645 is an FDA 510(k) premarket notification submitted by Pherdal Fertility Science, Inc. for the device "PherDal® At-Home Insemination Kit". The FDA issued a decision of Substantially Equivalent on December 14, 2023. The device falls under product code QYZ (At Home Intravaginal Insemination System), a Class II device regulated under 21 CFR 884.6110.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 14, 2023
- Date Received
- June 5, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- At Home Intravaginal Insemination System
- Device Class
- Class II
- Regulation Number
- 884.6110
- Review Panel
- OB
- Submission Type
To deliver semen to the vaginal canal for insemination.