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QYZ — At Home Intravaginal Insemination System Class II

FDA Device Classification

Classification Details

Product Code
QYZ
Device Class
Class II
Regulation Number
884.6110
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Definition

To deliver semen to the vaginal canal for insemination.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K232579hannah life technologies pteTwoplus ApplicatorDecember 21, 2023
K231645pherdal fertility sciencePherDal® At-Home Insemination KitDecember 14, 2023
K231203mosie babyMosie Baby KitNovember 29, 2023