510(k) Report

Devices descending from K122249

4 later devices reach Terumo SURGUARD3 Safety Needle & Hypodermic Syringe with Safety Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212095SurGuard3 Safety Hypodermic NeedleTerumo Europe N.V.20221—
+1K152362Terumo SurGuard 3 Safety Hypodermic NeedleTerumo (Philippines) Corporation20151—
+2K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R…Hangzhou Qiantang Longyue Biotechnology Co., Ltd.20260—
+2K251447K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)Terumo Europe N.V.20250—