POWERSEAL Curved Jaw Sealer and Divider, Double Action

K212643 is the FDA 510(k) clearance record for POWERSEAL Curved Jaw Sealer and Divider, Double Action, a class II device, cleared for Olympus Surgical Technologies America on 2021-09-27 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 13 510(k) clearances for Olympus Surgical Technologies America, from 2012-12-14 to 2026-07-24. As of 2026-09-10, FDA records show 7 recalls naming K212643.