Surgitron Iec II

K001986 is the FDA 510(k) clearance record for SURGITRON IEC II, a class II device, cleared for Ellman Intl., Inc. on 2000-09-27 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 21 510(k) clearances for Ellman Intl., Inc., from 1996-02-08 to 2011-01-05. As of 2026-09-10, FDA records show no recalls naming K001986.