Electrosurgical Electrode

K912597 is the FDA 510(k) clearance record for ELECTROSURGICAL ELECTRODE, a class II device, cleared for Megadyne Medical Products, Inc. on 1991-09-06 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 50 510(k) clearances for Megadyne Medical Products, Inc., from 1990-09-20 to 2024-07-12. As of 2026-09-10, FDA records show no recalls naming K912597.