
Ximed/Prosure/Injectx
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BIPOLAR ELECTROSURGICAL PROBES AND INSTRUMENTS is an FDA 510(k)-cleared medical device (K945995) manufactured by Ximed/Prosure/Injectx. 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 30, 1995. Regulation: 8.