510(k) K252889

Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) by Olympus Medical Systems Corporation — Product Code KNS

K252889 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corporation for the device "Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)". The FDA issued a decision of Substantially Equivalent on November 25, 2025. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Olympus Medical Systems Corporation has at least 10 other 510(k) clearances on record.