
Access Surgical Intl., Inc.
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ACCESS SURGICAL INT'L INC. ENDOSCOPIC SURG. INST. is an FDA 510(k)-cleared medical device (K933192) manufactured by Access Surgical Intl., 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 November 17, 1993. Regulation: 8.