510(k) K000079

NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M by Nikomed U.S.A., Inc. — Product Code HAM

K000079 is an FDA 510(k) premarket notification submitted by Nikomed U.S.A., Inc. for the device "NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M". The FDA issued a decision of Substantially Equivalent on February 4, 2000. The device falls under product code HAM (Apparatus, Electrosurgical), a Class II device regulated under 21 CFR 878.4400. Nikomed U.S.A., Inc. has at least 10 other 510(k) clearances on record.