510(k) K192679

Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use by Gemtier Medical (Shanghai), Inc. — Product Code MEG

K192679 is an FDA 510(k) premarket notification submitted by Gemtier Medical (Shanghai), Inc. for the device "Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use". The FDA issued a decision of Substantially Equivalent on April 10, 2020. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Gemtier Medical (Shanghai), Inc. has at least 4 other 510(k) clearances on record.