510(k) K211484

Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles by Shinva Ande Healthcare Apparatus Co., Ltd. — Product Code MEG

K211484 is an FDA 510(k) premarket notification submitted by Shinva Ande Healthcare Apparatus Co., Ltd. for the device "Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles". The FDA issued a decision of Substantially Equivalent on March 1, 2022. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Shinva Ande Healthcare Apparatus Co., Ltd. has at least 5 other 510(k) clearances on record.