510(k) K252646

Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) by Olympus Medical Systems Corp. — Product Code FCG

K252646 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corp. for the device "Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)". The FDA issued a decision of Substantially Equivalent on October 24, 2025. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. Olympus Medical Systems Corp. has at least 10 other 510(k) clearances on record.