Medical Device Manufacturer · US , Niles , IL

Sibel, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2021

Total

Cleared

Denied

FDA 510(k) Regulatory Record - Sibel, Inc. Cardiovascular ✕

2 devices

1-2 of 2

Linked clinical trials FDA-regulated device evidence

Regulatory consultant 510(k) submission support ecosystem

Third Party Review Group, LLC

Regulatory activity signals

510(k) clearance pathway relevance detected

Medical device regulatory intelligence node

Consulting ecosystem involvement present

Clinical validation data available

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 19, 2026