Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)

K253918 is the FDA 510(k) clearance record for Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St), a class II device, cleared for F Care Systems USA, LLC on 2026-06-02 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 4 510(k) clearances for F Care Systems USA, LLC, from 2021-12-17 to 2026-06-02. As of 2026-09-10, FDA records show no recalls naming K253918.