510(k) K242841

Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) by ABBOTT MEDICAL — Product Code GXI

K242841 is an FDA 510(k) premarket notification submitted by ABBOTT MEDICAL for the device "Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)". The FDA issued a decision of Substantially Equivalent on May 27, 2025. The device falls under product code GXI (Probe, Radiofrequency Lesion), a Class II device regulated under 21 CFR 882.4725. ABBOTT MEDICAL has at least 10 other 510(k) clearances on record.