
Oratec Interventions, Inc.
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ORATEC INTERVENTIONS MODEL ORASTAT MONOPOLAR CAUTERY DEVICE is an FDA 510(k)-cleared medical device (K973158) manufactured by Oratec Interventions, 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 November 4, 1997. Regulation: 8.