Enterix, Inc.

Medical device manufacturer in Edison, NJ.

3510(k) clearances
0PMA approvals
3recalls

Device types

510(k) clearances

510(k)DeviceDecision
K170548InSure ONEKHE · Traditional 10/05/2017SE
K060930Insure IIKHE · Special 05/04/2006SE
K002457!Nsure Fecal Occult Blood TestKHE · Traditional 01/12/2001SE

Recalls

RecallProductInitiated
Z-0725-2026 Class IIInSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit…InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false… 09/17/2025Open, Classified
Z-0590-2021 Class IIInSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively…Product does not meet internal testing criterion; use of the product may result in a potential false… 10/08/2020Terminated
Z-0480-2009 INSURE(R) QUIK FIT(TM) DEVELOPER KIT, Lot number B1478, Product Numbers: 30025 (InSure…False readings: Reduced sensitivity could affect the test line area and/or control line on the test strips… 10/03/2008Terminated