Medical Device Manufacturer · US , Sudbury , MA

Gentuity, LLC - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2020

Total

Cleared

Denied

Gentuity, LLC has 4 FDA 510(k) cleared medical devices. Based in Sudbury, US.

Latest FDA clearance: Jan 2025. Active since 2020. Primary specialty: Cardiovascular.

Browse the FDA 510(k) cleared devices submitted by Gentuity, LLC Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Mandell Horwitz Consultants, LLC as regulatory consultant.

Gentuity, LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Gentuity, LLC

4 devices

1-4 of 4

Data Source

Sourced from the FDA 510(k) public files . 175,450 total devices indexed.

Last updated: May 05, 2026