
Surgical Innovations Corp.
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SURGICAL INNOVATIONS DISPOSABLE ENDOSCOPIC HERNIA SURGICAL STAPLER SURGICAL INNOVATIONS RESUABLE SURGICAL STAPLER HANDLE is an FDA 510(k)-cleared medical device (K944292) manufactured by Surgical Innovations Corp.. 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 November 14, 1994. Regulation: 8.