
Meadox Surgimed, Inc.
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MEADOX(R) SURGIMED(R) BIOPSY GUN II is an FDA 510(k)-cleared medical device (K911635) manufactured by Meadox Surgimed, 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 June 19, 1991. Regulation: 8.