PherDal® At-Home Insemination Kit
K-Number: K231645 · 2023-12-14
ApplicantPherdal Fertility Science, Inc.
Decision Date2023-12-14
Product CodeQYZ
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
PherDal® At-Home Insemination Kit is a medical device manufactured by Pherdal Fertility Science, Inc.. It received FDA 510(k) clearance on 2023-12-14 under approval number K231645. The device is classified under product code QYZ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PherDal® At-Home Insemination Kit?
PherDal® At-Home Insemination Kit is a medical device that received FDA 510(k) clearance on 2023-12-14. It is manufactured by Pherdal Fertility Science, Inc.. The 510(k) number is K231645.
When was PherDal® At-Home Insemination Kit approved by the FDA?
PherDal® At-Home Insemination Kit received FDA 510(k) clearance on 2023-12-14, under approval number K231645.
What company makes PherDal® At-Home Insemination Kit?
PherDal® At-Home Insemination Kit is manufactured by Pherdal Fertility Science, Inc..
What is the FDA product code for PherDal® At-Home Insemination Kit?
The FDA product code for PherDal® At-Home Insemination Kit is QYZ.
Related Devices (Code: QYZ)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.