Electrosurgery Analyzer Rf302

K893659 is the FDA 510(k) clearance record for ELECTROSURGERY ANALYZER RF302, a class II device, cleared for Bio-Tek Instruments, Inc. on 1989-07-14 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 37 510(k) clearances for Bio-Tek Instruments, Inc., from 1980-04-02 to 1997-12-18. As of 2026-09-10, FDA records show no recalls naming K893659.