510(k) Report

Devices descending from K970370

9 later devices reach TSK Sterijekt Premium Disposable Hypodermic Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231734STERiJECT Low Dead Space, STERiJECT The Invisible NeedleTsk Laboratory International Japan KK20240—
+1K231261Altaviz Needle Kit IIAltaviz, LLC20230—
+1K151571Mini NeedleOcujet, LLC20156—
+2K170768Mini NeedleOcuject, LLC20175—
+3K183016SteriCap Mini NeedleOcujet, LLC20194—
+4K212805SteriCap Mini Needle and Standard NeedlesOcuject, LLC20213—
+5K242956LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety NeedleOcuject, LLC20240—
+5K233343SteriCap Safety Needle; VitreJect Safety NeedleOcuject, LLC20231—
+5K230959VitreJect® Needle; OcuSafe® NeedleOcuject, LLC20232—