DeviceClearance

Product code OYO— Obstetrics/Gynecology

INVOcell

Classification name
Culture, Intravaginal, Assisted Reproduction
Device class
Class 2
Regulation
21 CFR 884.6165
Advisory panel
Obstetrics/Gynecology
Total cleared
2
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code OYO under 21 CFR 884.6165, via openFDA

Market context for product code OYO

FDA has cleared 2 devices under product code OYO between 2015 and 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OYO

Recent clearances under product code OYO

Data sourced from openFDA. This site is unofficial and independent of the FDA.