510(k) K252908

Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle by Sandstone Medical (Suzhou), Inc. — Product Code FMI

K252908 is an FDA 510(k) premarket notification submitted by Sandstone Medical (Suzhou), Inc. for the device "Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle". The FDA issued a decision of Substantially Equivalent on March 25, 2026. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Sandstone Medical (Suzhou), Inc. has at least 2 other 510(k) clearances on record.