UltiCare Disposable Pen Needles

UltiCare Disposable Pen Needles is an FDA 510(k)-cleared medical device (K213407) manufactured by Ultimed Incorporated. 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 December 15, 2021. Regulation: 8.