Bergen 610 Bipolar Coagulator

K964736 is the FDA 510(k) clearance record for BERGEN 610 BIPOLAR COAGULATOR, a class II device, cleared for Bergen Mfg. on 1997-02-27 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 4 510(k) clearances for Bergen Mfg., from 1986-10-14 to 1997-08-27. As of 2026-09-10, FDA records show no recalls naming K964736.