Prevena Restor Adapti-Form Dressing

Prevena Restor Adapti-Form Dressing is an FDA 510(k)-cleared medical device (K220660) manufactured by 3M Healthcare Business Group. 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 30, 2022. Regulation: 8.