
Innerdyne, Inc.
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INNERDYNE STEP TROCAR EXPANDABLE PORT, MINISTEP is an FDA 510(k)-cleared medical device (K961430) manufactured by Innerdyne, Inc.. 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 May 27, 1996. Regulation: 8.