
Apollo Endosurgery, Inc.
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X-Tack Endoscopic HeliX Tacking System is an FDA 510(k)-cleared medical device (K201808) manufactured by Apollo Endosurgery, 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 December 14, 2020. Regulation: 8.