510(k) K100275

WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS by Olympus Winter & Ibe GmbH — Product Code FAS

K100275 is an FDA 510(k) premarket notification submitted by Olympus Winter & Ibe GmbH for the device "WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS". The FDA issued a decision of Substantially Equivalent on July 1, 2010. 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.