OYO — Culture, Intravaginal, Assisted Reproduction Class II

FDA Device Classification

Classification Details

Product Code
OYO
Device Class
Class II
Regulation Number
884.6165
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Definition

Intravaginal culture of human gametes and embryos. To hold and maintain gametes and developing embryos over the duration of the intravaginal culture period.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K222932invo bioscienceINVOcell Intravaginal Culture SystemJune 22, 2023
DEN150008invo bioscienceINVOcellNovember 2, 2015