510(k) K180449

Single Use Aspiration Needle NA-U200H by Olympus Medical Systems Corp. — Product Code FCG

K180449 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corp. for the device "Single Use Aspiration Needle NA-U200H". The FDA issued a decision of Substantially Equivalent on June 8, 2018. 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.