DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES

DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES is an FDA 510(k)-cleared medical device (K970511) manufactured by Smith & Nephew, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 11, 1997. Regulation: 8.