Curon Control Module Electrosurgical Generator and Accessories, Model S500-St

K002898 is the FDA 510(k) clearance record for CURON CONTROL MODULE ELECTROSURGICAL GENERATOR AND ACCESSORIES, MODEL S500-ST, a class II device, cleared for Curon Medical, Inc. on 2000-10-17 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 5 510(k) clearances for Curon Medical, Inc., from 2000-10-17 to 2015-09-23. As of 2026-09-10, FDA records show no recalls naming K002898.