Mccain Monopolar & Bipolar Cautery

K881403 is the FDA 510(k) clearance record for MCCAIN MONOPOLAR & BIPOLAR CAUTERY, a class II device, cleared for Walter Lorenz Surgical, Inc. on 1988-06-22 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 86 510(k) clearances for BIOMET MICROFIXATION, from 1986-01-21 to 2026-06-02. As of 2026-09-10, FDA records show no recalls naming K881403.