510(k) K102781

RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS by Olympus Winter & Ibe GmbH — Product Code FAS

K102781 is an FDA 510(k) premarket notification submitted by Olympus Winter & Ibe GmbH for the device "RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS". The FDA issued a decision of Substantially Equivalent on January 11, 2011. 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.