
Enterix, Inc.
Free shipping on orders over $99 · 30-day returns
InSure ONE is an FDA 510(k)-cleared medical device (K170548) manufactured by Enterix, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 4, 2017. Regulation: 8.