Home / 510(k) Clearances / K231645

510(k) K231645

PherDal® At-Home Insemination Kit by Pherdal Fertility Science, Inc. — Product Code QYZ

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.