FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Pherdal Fertility Science, Inc.. It received FDA 510(k) clearance on 2023-12-14 under 510(k) 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. The listed applicant is Pherdal Fertility Science, Inc.. The 510(k) number is K231645.

When did PherDal® At-Home Insemination Kit receive FDA 510(k) clearance?

PherDal® At-Home Insemination Kit received FDA 510(k) clearance on 2023-12-14, under 510(k) number K231645.

Who is the listed applicant for PherDal® At-Home Insemination Kit?

The FDA 510(k) record lists Pherdal Fertility Science, Inc. as the applicant. This does not by itself establish the device manufacturer.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232579Twoplus ApplicatorHannah Life Technologies Pte , Ltd.K231203Mosie Baby KitMosie Baby

Official Source

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