Uniblate Electrosurgical Device

K070101 is the FDA 510(k) clearance record for UNIBLATE ELECTROSURGICAL DEVICE, a class II device, cleared for Rita Medical Systems, Inc. on 2007-02-14 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 1,110 510(k) clearances for Boston Scientific Corporation, from 1988-11-23 to 2026-08-12. As of 2026-09-10, FDA records show no recalls naming K070101.