OYO

Culture, Intravaginal, Assisted Reproduction

Product code

OYO

Device name

Culture, Intravaginal, Assisted Reproduction

Device class

Class 2

21 CFR

21 CFR 884.6165

Medical specialty

Obstetrics/Gynecology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).