Medical Device Manufacturer · US , Falmouth, , ME

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

3 submissions · 3 cleared · Since 2001

Recent clearances: InSure ONE, INSURE II, !NSURE FECAL OCCULT BLOOD TEST

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Enterix, Inc. Hematology ✕

3 devices

1-3 of 3

Cleared Oct 05, 2017

Hematology · 223d

Cleared May 04, 2006

Hematology · 29d

Cleared Jan 12, 2001

!NSURE FECAL OCCULT BLOOD TEST

Hematology · 155d

Data Source

Sourced from the FDA 510(k) public files . 176,583 total devices indexed.

Last updated: Sep 14, 2026