Medical Device Manufacturer · US , Minneapolis , MN

Pelvital USA, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2020

Total

Cleared

Denied

Pelvital USA, Inc. has 5 FDA 510(k) cleared medical devices. Based in Minneapolis, US.

Latest FDA clearance: Aug 2024. Active since 2020. Primary specialty: Gastroenterology & Urology.

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

Regulatory submissions have been managed by Winegar Consulting, Inc., Hetrick Medical Device Consulting, LLC and RQM+.

Pelvital USA, 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 - Pelvital USA, 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 10, 2026