510(k) Report

Devices descending from K111797

2 later devices reach 27 G X 1/2 K-Pack Surshield Needle through their predicates, nearest generation first.

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