510(k) K892895

MODEL 8800 BIPOLAR COAGULATION THERAPEUTIC SYSTEM by Everest Medical Corp. — Product Code KNS

K892895 is an FDA 510(k) premarket notification submitted by Everest Medical Corp. for the device "MODEL 8800 BIPOLAR COAGULATION THERAPEUTIC SYSTEM". The FDA issued a decision of Substantially Equivalent on September 25, 1989. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Everest Medical Corp. has at least 10 other 510(k) clearances on record.