
Usgi Medical
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USGI SHAPELOCK ENDOSCOPIC GUIDE is an FDA 510(k)-cleared medical device (K050253) manufactured by Usgi Medical. 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 February 27, 2005. Regulation: 8.

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