
Sutura, Inc.
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SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW is an FDA 510(k)-cleared medical device (K053482) manufactured by Sutura, 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 December 26, 2005. Regulation: 8.