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Smith & Nephew Inc., Endoscopy Div.
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ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM is an FDA 510(k)-cleared medical device (K111843) manufactured by Smith & Nephew Inc., Endoscopy Div.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 13, 2011. Regulation: 8.