Altrus Thermal Tissue Fusion Energy Source, Altrus Thermal Tissue Fusion Handpiece, Altrus Thermal Tissue Fusion System

K140459 is the FDA 510(k) clearance record for ALTRUS THERMAL TISSUE FUSION ENERGY SOURCE, ALTRUS THERMAL TISSUE FUSION HANDPIECE, ALTRUS THERMAL TISSUE FUSION SYSTEM, a class II device, cleared for Conmed Corporation on 2014-07-11 under FDA product code GEI (Electrosurgical, Cutting & Coagulation & Accessories). FDA's definition for product code GEI reads: "Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available...". FDA records list 84 510(k) clearances for Conmed Corporation, from 2004-08-31 to 2026-05-13. As of 2026-09-10, FDA records show one recall naming K140459.