
Top Surgical Manufacturers Co.
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TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE is an FDA 510(k)-cleared medical device (K844343) manufactured by Top Surgical Manufacturers Co.. 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 January 7, 1985. Regulation: 8.