510(k) K253622

Safety Pen Needle by Ningbo Medsun Medical Co., Ltd. — Product Code FMI

K253622 is an FDA 510(k) premarket notification submitted by Ningbo Medsun Medical Co., Ltd. for the device "Safety Pen Needle". The FDA issued a decision of Substantially Equivalent on March 18, 2026. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Ningbo Medsun Medical Co., Ltd. has at least 6 other 510(k) clearances on record.