Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories

K192124 is the FDA 510(k) clearance record for Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories, a class II device, cleared for Us Medical Innovations, LLC on 2019-11-21 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 5 510(k) clearances for Us Medical Innovations, LLC, from 2011-04-06 to 2024-05-03. As of 2026-09-10, FDA records show no recalls naming K192124.