510(k) K212518

Jeesung Safety Syringe and Single Use Needles by Jeesung Medical Co., Ltd. — Product Code MEG

K212518 is an FDA 510(k) premarket notification submitted by Jeesung Medical Co., Ltd. for the device "Jeesung Safety Syringe and Single Use Needles". The FDA issued a decision of Substantially Equivalent on August 18, 2022. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Jeesung Medical Co., Ltd. has at least 2 other 510(k) clearances on record.