
Innerdyne Medical, Inc.
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INNERDYNE STEP TROCAR EXPANDABLE PORT, S.T.E.P. is an FDA 510(k)-cleared medical device (K940232) manufactured by Innerdyne Medical, 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 April 17, 1994. Regulation: 8.