
General Surgical Innovations
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SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, SAPHTRAK is an FDA 510(k)-cleared medical device (K973046) manufactured by General Surgical Innovations. 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 15, 1998. Regulation: 8.