510(k) K210216

Disposable Automatically Retractable Insulin Safety Syringe by Shantou Wealy Medical Instrument Co.,Ltd — Product Code MEG

K210216 is an FDA 510(k) premarket notification submitted by Shantou Wealy Medical Instrument Co.,Ltd for the device "Disposable Automatically Retractable Insulin Safety Syringe". The FDA issued a decision of Substantially Equivalent on March 4, 2022. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Shantou Wealy Medical Instrument Co.,Ltd has at least 5 other 510(k) clearances on record.