
Calyxo, Inc.
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CVAC Aspiration System is an FDA 510(k)-cleared medical device (K260965) manufactured by Calyxo, Inc.. 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 April 12, 2026. Regulation: 8.