510(k) K232632

Racz Neurostat RF Generator by Epimed International — Product Code GXD

K232632 is an FDA 510(k) premarket notification submitted by Epimed International for the device "Racz Neurostat RF Generator". The FDA issued a decision of Substantially Equivalent on May 24, 2024. The device falls under product code GXD (Generator, Lesion, Radiofrequency), a Class II device regulated under 21 CFR 882.4400. Epimed International has at least 10 other 510(k) clearances on record.