SteriCap Safety Needle; VitreJect Safety Needle

SteriCap Safety Needle; VitreJect Safety Needle is an FDA 510(k)-cleared medical device (K233343) manufactured by Ocuject, 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 November 26, 2023. Regulation: 8.