Medical Device Manufacturer · US , Lutsen , MN

Gc Medtech, LLC - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2014

Recent clearances: E-App, GENTLECARE AR APPLICATOR

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Gc Medtech, LLC Radiology ✕

2 devices

1-2 of 2

Cleared May 20, 2015

Radiology · 239d

Cleared Apr 18, 2014

GENTLECARE AR APPLICATOR

Radiology · 116d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 20, 2026