Medical Device Manufacturer · US , San Jose , CA

OTU Medical, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2018

Total

Cleared

Denied

OTU Medical, Inc. has 5 FDA 510(k) cleared medical devices. Based in San Jose, US.

Last cleared in 2023. Active since 2018. Primary specialty: Gastroenterology & Urology.

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

Regulatory submissions have been managed by Zi-medical, Inc., Third Party Review Group, LLC and Zi-Medical.

OTU Medical, Inc. 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 - OTU Medical, Inc.

5 devices

1-5 of 5

Data Source

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

Last updated: May 15, 2026