510(k) Report

Devices descending from K192057

2 later devices reach K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2”… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230951Terumo Injection Filter Needle (NF-3013RBKE05M)Terumo Europe N.V.20231—
+2K242073STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)Tsk Laboratory International Japan KK20240—