510(k) Report

Devices descending from K110527

3 later devices reach K-Pack Surshield Needle, Hypodermic Needle for Single Use through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K11179727 G X 1/2 K-Pack Surshield NeedleTerumo Europe N.V.20112—
+2K24330927G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)Terumo Europe N.V.20250—
+2K223353DropSafeTM SicuraTMPikdare Spa20220—