510(k) K003405

ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO by Highland / Marietta, Inc. — Product Code KNF

K003405 is an FDA 510(k) premarket notification submitted by Highland / Marietta, Inc. for the device "ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO". The FDA issued a decision of Substantially Equivalent on May 7, 2001. The device falls under product code KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4160. Highland / Marietta, Inc. has at least 1 other 510(k) clearance on record.