Insignis™ Syringe Infusion System

Insignis™ Syringe Infusion System is an FDA 510(k)-cleared medical device (K232328) manufactured by Innovative Health Sciences, LLC. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 29, 2024. Regulation: 8.