510(k) K130305

LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE by Lina Medical Aps — Product Code HIN

K130305 is an FDA 510(k) premarket notification submitted by Lina Medical Aps for the device "LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE". The FDA issued a decision of Substantially Equivalent on July 24, 2013. The device falls under product code HIN (Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4150. Lina Medical Aps has at least 10 other 510(k) clearances on record.