510(k) K864413

MODEL HSE-5M MICROWAVE SURGERY EQUIPMENT/MICROTAZE by Cooper Lasersonics, Inc. — Product Code KNS

K864413 is an FDA 510(k) premarket notification submitted by Cooper Lasersonics, Inc. for the device "MODEL HSE-5M MICROWAVE SURGERY EQUIPMENT/MICROTAZE". The FDA issued a decision of Substantially Equivalent on December 9, 1986. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Cooper Lasersonics, Inc. has at least 10 other 510(k) clearances on record.