Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand

Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand is an FDA 510(k)-cleared medical device (K210423) manufactured by ArthroCare Corporation. 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 June 23, 2021. Regulation: 8.