
Asensus Surgical
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Senhance Ultrasonic System is an FDA 510(k)-cleared medical device (K254192) manufactured by Asensus Surgical. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 11, 2026. Regulation: 8.