
Vidamed, Inc.
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VIDAMED TUNA (TRANSURETHRAL NEEDLE ABLATION) SYSTEM is an FDA 510(k)-cleared medical device (K960918) manufactured by Vidamed, 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 October 7, 1996. Regulation: 8.