
Genicon, LC
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SHIELDEDTROCAR/CANNULA SYSTEM, MODEL 101-005-101 is an FDA 510(k)-cleared medical device (K991382) manufactured by Genicon, LC. 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 July 14, 1999. Regulation: 8.