
Access Surgical Intl., Inc.
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ACCESS SURGICAL MONOPOLAR ENDOSCOPIC SURG. INSTRUM is an FDA 510(k)-cleared medical device (K922425) manufactured by Access Surgical Intl., Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 16, 1992. Regulation: 8.