510(k) K210651

Resection Electrodes with HF cable by Olympus Winter & Ibe GmbH — Product Code FAS

K210651 is an FDA 510(k) premarket notification submitted by Olympus Winter & Ibe GmbH for the device "Resection Electrodes with HF cable". The FDA issued a decision of Substantially Equivalent on August 3, 2021. 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.