510(k) K132135

LINA GOLD LOOP HC by Lina Medical Aps — Product Code KNF

K132135 is an FDA 510(k) premarket notification submitted by Lina Medical Aps for the device "LINA GOLD LOOP HC". The FDA issued a decision of Substantially Equivalent on January 31, 2014. The device falls under product code KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4160. Lina Medical Aps has at least 10 other 510(k) clearances on record.