
Aatru Medical, LLC
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npSIMS Negative Pressure Surgical Incision Management System (npSIMS) is an FDA 510(k)-cleared medical device (K201400) manufactured by Aatru Medical, 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 22, 2021. Regulation: 8.