Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)

Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) is an FDA 510(k)-cleared medical device (K243187) manufactured by Cork Medical. 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 26, 2025. Regulation: 8.