ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 45 cm Shaft Length

K180403 is the FDA 510(k) clearance record for ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 45 cm Shaft Length, a class II device, cleared for Ethicon Endo-Surgery, LLC on 2018-05-23 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 185 510(k) clearances for Ethicon Endo-Surgery, LLC, from 1992-09-09 to 2026-05-11. As of 2026-09-10, FDA records show no recalls naming K180403.