K231645 is an FDA 510(k) clearance for the PherDal® At-Home Insemination Kit. This device is classified as a At Home Intravaginal Insemination System (Class II - Special Controls, product code QYZ).
Submitted by Pherdal Fertility Science, Inc. (Dixon, US). The FDA issued a Cleared decision on December 14, 2023, 192 days after receiving the submission on June 5, 2023.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6110. To Deliver Semen To The Vaginal Canal For Insemination..
| 510(k) Number | K231645 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 2023 |
| Decision Date | December 14, 2023 |
| Days to Decision | 192 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | QYZ - At Home Intravaginal Insemination System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6110 |
| Definition | To Deliver Semen To The Vaginal Canal For Insemination. |