510(k) K213135

Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge by Chirurgie Innovation — Product Code FAS

K213135 is an FDA 510(k) premarket notification submitted by Chirurgie Innovation for the device "Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge". The FDA issued a decision of Substantially Equivalent on March 2, 2022. The device falls under product code FAS (Electrode, Electrosurgical, Active, Urological), a Class II device regulated under 21 CFR 876.4300. Chirurgie Innovation has at least 1 other 510(k) clearance on record.