510(k) K070315

LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8 by Lina Medical Aps — Product Code KNF

K070315 is an FDA 510(k) premarket notification submitted by Lina Medical Aps for the device "LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8". The FDA issued a decision of Substantially Equivalent on October 30, 2007. 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.