Surgitron 4.0 Dual RF S5-Iec

K123366 is the FDA 510(k) clearance record for SURGITRON 4.0 DUAL RF S5-IEC, a class II device, cleared for Ellman International, Inc. on 2013-07-12 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 Ellman International, Inc., from 2006-02-24 to 2014-02-20. As of 2026-09-10, FDA records show one recall naming K123366.