510(k) K030194

XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT by The Olympus Optical Co. — Product Code KNS

K030194 is an FDA 510(k) premarket notification submitted by The Olympus Optical Co. for the device "XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT". The FDA issued a decision of Substantially Equivalent on March 24, 2003. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. The Olympus Optical Co. has at least 10 other 510(k) clearances on record.