FDA Product Code QYZ: At Home Intravaginal Insemination System
To Deliver Semen To The Vaginal Canal For Insemination.
Leading manufacturers include Mosie Baby, Pherdal Fertility Science, Inc. and Hannah Life Technologies Pte , Ltd..
3
Total
3
Cleared
175d
Avg days
2023
Since
Declining activity -
0 submissions in the last 2 years
vs 3 in the prior period
FDA 510(k) Cleared At Home Intravaginal Insemination System Devices (Product Code QYZ)
3 devices
Cleared
Dec 21, 2023
Twoplus Applicator
Hannah Life Technologies Pte , Ltd.
Obstetrics & Gynecology
118d
Cleared
Dec 14, 2023
PherDal® At-Home Insemination Kit
Pherdal Fertility Science, Inc.
Obstetrics & Gynecology
192d
Cleared
Nov 29, 2023
Mosie Baby Kit
Mosie Baby
Obstetrics & Gynecology
216d
About Product Code QYZ - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code QYZ since 2023, with 3 receiving FDA clearance (average review time: 175 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 3 in the prior period.
QYZ devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →