Medical Device Manufacturer · US , Sunnyvale , CA

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

3 submissions · 3 cleared · Since 2015

3

Total

3

Cleared

0

Denied

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

3 devices

1-3 of 3

Cleared Mar 04, 2016

Endophys Pressure Sensing Sheath Kit

Cardiovascular · 31d

Cleared Jan 07, 2015

ENDOPHYS PRESSURE SENSING SHEATH KIT

Cardiovascular · 236d

Cleared Jan 07, 2015

ENDOPHYS BLOOD PRESSURE MONITOR

Cardiovascular · 205d

Data Source

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

Last updated: Apr 28, 2026