510(k) K250284

TSK SELECT™ Needle by Tsk Laboratory, Japan — Product Code FMI

K250284 is an FDA 510(k) premarket notification submitted by Tsk Laboratory, Japan for the device "TSK SELECT™ Needle". The FDA issued a decision of Substantially Equivalent on July 24, 2025. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Tsk Laboratory, Japan has at least 2 other 510(k) clearances on record.