510(k) K871745

MODEL 26021C BIPOLAR COAGULATOR by KARL STORZ Endoscopy-America, Inc. — Product Code HIN

K871745 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "MODEL 26021C BIPOLAR COAGULATOR". The FDA issued a decision of Substantially Equivalent on July 10, 1987. The device falls under product code HIN (Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4150. KARL STORZ Endoscopy-America, Inc. has at least 10 other 510(k) clearances on record.