Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Enterix with 3 510(k) clearances and 2 device recalls. The most recent is a device recall dated Sep 17, 2025: InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient K….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 17, 2025 | InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure ONE Class II · InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results. | Device recalls |
| Oct 8, 2020 | InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples MClass II · Product does not meet internal testing criterion; use of the product may result in a potential false positive test resul | Device recalls |
| Oct 5, 2017 | InSure ONEK170548 · KHE | 510(k) clearances |
| May 4, 2006 | INSURE IIK060930 · KHE | 510(k) clearances |
| Jan 12, 2001 | !NSURE FECAL OCCULT BLOOD TESTK002457 · KHE | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
