
Schneider Intl., Ltd.
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BILIARY ENDOPROSTHESES W/UNISTEP DELIVERY SYSTEM is an FDA 510(k)-cleared medical device (K925406) manufactured by Schneider Intl., Ltd.. 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 January 10, 1995. Regulation: 8.