510(k) K193422

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

K193422 is an FDA 510(k) premarket notification submitted by Sandstone Medical (Suzhou), Inc. for the device "Easydrip Pen Needle, Easydrip Plus Pen Needle". The FDA issued a decision of Substantially Equivalent on February 2, 2021. 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.