Enterix, Inc.
Enterix, Inc. holds FDA 510(k) medical device clearances, first cleared 2001, most recent 2017, with 2 FDA device recalls on record.
Top product codes for Enterix, Inc.
FDA recalls by Enterix, Inc.
- Z-0725-2026 — InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure ONE POL Patient Kit - 25 Pack. Model Number: 90025. 3. InSure ONE POL Combo Pack. Model Number: 90030. InSure ONE is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples.
- Z-0590-2021 — InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Enterix, Inc.
Data sourced from openFDA. This site is unofficial and independent of the FDA.