FDA Product Code OYO: Culture, Intravaginal, Assisted Reproduction
Intravaginal Culture Of Human Gametes And Embryos. To Hold And Maintain Gametes And Developing Embryos Over The Duration Of The Intravaginal Culture Period.
Leading manufacturers include Invo Bioscience.
2
Total
1
Cleared
261d
Avg days
2015
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Culture, Intravaginal, Assisted Reproduction Devices (Product Code OYO)
2 devices
About Product Code OYO - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code OYO since 2015, with 1 receiving FDA clearance (average review time: 261 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
OYO devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →