Medical Device Manufacturer · US , Charlotte , NC

Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) - FDA 510(k) Cleare...

1 submissions · 1 cleared · Since 2025

Total

Cleared

Denied

FDA 510(k) Regulatory Record - Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) Gastroenterology & Urology ✕

1 devices

1-1 of 1

Linked clinical trials FDA-regulated device evidence

Regulatory consultant 510(k) submission support ecosystem

Hogan Lovells US LLP

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: Apr 27, 2026