510(k) K250994

ClearTip FNA and FNB Types by Finemedix Co., Ltd. — Product Code FCG

K250994 is an FDA 510(k) premarket notification submitted by Finemedix Co., Ltd. for the device "ClearTip FNA and FNB Types". The FDA issued a decision of Substantially Equivalent on August 21, 2025. 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.