About This 510(k) Submission
K213135 is an FDA 510(k) clearance for the Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge, a Electrode, Electrosurgical, Active, Urological (Class II — Special Controls, product code FAS), submitted by Chirurgie Innovation (Verri?res Le Buisson, FR). The FDA issued a Cleared decision on March 2, 2022, 156 days after receiving the submission on September 27, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.