Medical Device Manufacturer · US , Salt Lake City , UT

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

2 submissions · 2 cleared · Since 2018

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Elute, Inc. Orthopedic ✕

2 devices

1-2 of 2

Cleared Feb 26, 2025

Orthopedic · 20d

Cleared Aug 06, 2018

EP Granules™ BVF

Orthopedic · 126d

Data Source

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

Last updated: May 04, 2026