510(k) K250351

Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U) by Olympus Medical Systems Corporation — Product Code KNS

K250351 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corporation for the device "Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)". The FDA issued a decision of Substantially Equivalent on October 10, 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.