
Actuated Medical, Inc.
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TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS) is an FDA 510(k)-cleared medical device (K131052) manufactured by Actuated Medical, 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 August 15, 2013. Regulation: 8.