510(k) K232165

Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles by Berpu Medical Technology Co., Ltd. — Product Code FMI

K232165 is an FDA 510(k) premarket notification submitted by Berpu Medical Technology Co., Ltd. for the device "Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles". The FDA issued a decision of Substantially Equivalent on February 1, 2024. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Berpu Medical Technology Co., Ltd. has at least 8 other 510(k) clearances on record.