510(k) K180363

Clear-Tip EUS-FNA by Finemedix Co., Ltd. — Product Code FCG

K180363 is an FDA 510(k) premarket notification submitted by Finemedix Co., Ltd. for the device "Clear-Tip EUS-FNA". The FDA issued a decision of Substantially Equivalent on November 1, 2018. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. Finemedix Co., Ltd. has at least 10 other 510(k) clearances on record.