510(k) K213811

Sterile Hypodermic Syringes for Single Use by Berpu Medical Technology Co., Ltd. — Product Code FMF

K213811 is an FDA 510(k) premarket notification submitted by Berpu Medical Technology Co., Ltd. for the device "Sterile Hypodermic Syringes for Single Use". The FDA issued a decision of Substantially Equivalent on May 12, 2022. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Berpu Medical Technology Co., Ltd. has at least 8 other 510(k) clearances on record.