510(k) K041021

RF INTRODUCTION CANNULA by Epimed International, Inc. — Product Code GXI

K041021 is an FDA 510(k) premarket notification submitted by Epimed International, Inc. for the device "RF INTRODUCTION CANNULA". The FDA issued a decision of Substantially Equivalent on September 16, 2004. The device falls under product code GXI (Probe, Radiofrequency Lesion), a Class II device regulated under 21 CFR 882.4725. Epimed International, Inc. has at least 10 other 510(k) clearances on record.