
Covidien, LLC
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GastriSail Gastric Positioning System 40 Fr/CH (13.3mm) is an FDA 510(k)-cleared medical device (K160654) manufactured by Covidien, LLC. 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 3, 2016. Regulation: 8.