510(k) K180668

Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N by Olympus Medical Systems Corp. — Product Code FCG

K180668 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corp. for the device "Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N". The FDA issued a decision of Substantially Equivalent on November 15, 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.