510(k) K120418

ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES by Olympus Winter & Ibe GmbH — Product Code FAS

K120418 is an FDA 510(k) premarket notification submitted by Olympus Winter & Ibe GmbH for the device "ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES". The FDA issued a decision of Substantially Equivalent on June 20, 2012. The device falls under product code FAS (Electrode, Electrosurgical, Active, Urological), a Class II device regulated under 21 CFR 876.4300. Olympus Winter & Ibe GmbH has at least 10 other 510(k) clearances on record.