Disposable Monopolar Laparoscopic Tips and Reusable Handles

Disposable Monopolar Laparoscopic Tips and Reusable Handles is an FDA 510(k)-cleared medical device (K211019) manufactured by Dannik, 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 October 27, 2021. Regulation: 8.