510(k) K121773

NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE by Biomerics — Product Code GXI

K121773 is an FDA 510(k) premarket notification submitted by Biomerics for the device "NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE". The FDA issued a decision of Substantially Equivalent on September 21, 2012. The device falls under product code GXI (Probe, Radiofrequency Lesion), a Class II device regulated under 21 CFR 882.4725. Biomerics has at least 1 other 510(k) clearance on record.