Invo Bioscience - FDA 510(k) Cleared Devices

Invo Bioscience, is a fertility technology company focused on Obstetrics & Gynecology devices. The company operates fertility clinics and develops innovative reproductive technologies to expand access to advanced fertility care.

The company has received 1 FDA 510(k) clearance from 2 total submissions in the Obstetrics & Gynecology category. The first clearance was granted in 2015, with the most recent in 2023. This represents a historical regulatory record; the company has not pursued new FDA 510(k) submissions in recent years.

INVOcell Intravaginal Culture System is the company's flagship cleared device. It enables fertilization and early embryo development within the woman's body, reducing treatment costs and improving clinical efficiency in fertility care.

Explore the complete regulatory history, device names, product codes, and clearance dates in the 510(k) database.

510(k) submissions have been managed by Avania, LLC as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov.