
Innoblative Designs, Inc.
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SIRA RFA Electrosurgical Device is an FDA 510(k)-cleared medical device (K181071) manufactured by Innoblative Designs, 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 January 15, 2019. Regulation: 8.