Barrx Anorectal RFA Wand

Barrx Anorectal RFA Wand is an FDA 510(k)-cleared medical device (K162802) manufactured by Covidien, LLC. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 23, 2017. Regulation: 8.