510(k) Report

Devices descending from K212095

1 later device reach SurGuard3 Safety Hypodermic Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251447K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)Terumo Europe N.V.20250—