510(k) K212920

Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use by Shandong Weigao Group Medical Polymer Co., Ltd. — Product Code FMF

K212920 is an FDA 510(k) premarket notification submitted by Shandong Weigao Group Medical Polymer Co., Ltd. for the device "Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use". The FDA issued a decision of Substantially Equivalent on Mar 11, 2022. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Shandong Weigao Group Medical Polymer Co., Ltd. has 6 other 510(k) clearances on record.