510(k) K981464

OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE by Omnitech Systems, Inc. — Product Code KNF

K981464 is an FDA 510(k) premarket notification submitted by Omnitech Systems, Inc. for the device "OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE". The FDA issued a decision of Substantially Equivalent on July 10, 1998. The device falls under product code KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4160. Omnitech Systems, Inc. has at least 5 other 510(k) clearances on record.