Cryo-Hit Model Numbers Ep3t3, Ep5t2, Ep5t5, Ep7t5, Ep8t5

K980913 is the FDA 510(k) clearance record for CRYO-HIT MODEL NUMBERS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5, a class II device, cleared for Galil Medical , Ltd. on 1998-07-01 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 31 510(k) clearances for Galil Medical , Ltd., from 1998-07-01 to 2020-11-02. As of 2026-09-10, FDA records show no recalls naming K980913.