510(k) K182408

Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645 by Olympus Medical Systems Corp. — Product Code KNS

K182408 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corp. for the device "Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645". The FDA issued a decision of Substantially Equivalent on May 15, 2019. 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 Corp. has 103 other 510(k) clearances on record.