
Smith & Nephew Dyonics, Inc.
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SMITH & NEPHEW DYONICS LAPAROSCOPY SYSTEM is an FDA 510(k)-cleared medical device (K914919) manufactured by Smith & Nephew Dyonics, 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 January 8, 1992. Regulation: 8.