Disposable Monopolar Laparoscopic Shafts and Reusable Handles

Disposable Monopolar Laparoscopic Shafts and Reusable Handles is an FDA 510(k)-cleared medical device (K210569) 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 August 15, 2021. Regulation: 8.