
Ximed/Prosure/Injectx
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INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX is an FDA 510(k)-cleared medical device (K983200) manufactured by Ximed/Prosure/Injectx. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 10, 1998. Regulation: 8.