Aaron C Size(tm) High Temperature Cautery

K870397 is the FDA 510(k) clearance record for AARON C SIZE(TM) HIGH TEMPERATURE CAUTERY, a class II device, cleared for Sunkey Medical Manufacturing, Inc. on 1987-03-18 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 one 510(k) clearance for Sunkey Medical Manufacturing, Inc. As of 2026-09-10, FDA records show no recalls naming K870397.