SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE

SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE is an FDA 510(k)-cleared medical device (K936071) manufactured by Smith & Nephew Dyonics, Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 18, 1994. Regulation: 8.