# K230387: ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSLX137C); ENSEAL X1 Curved Tissue Sealers, 45 cm shaft ength (NSLX137C); ENSEAL X1 Straight Tissue Sealers, 25 cm shaft length (NSLX125S); ENSEAL X1 Straight Tissue Sealers, 37 cm shaft length (NSLX137S) - Pathway: 510(k) (Traditional) - Applicant: Ethicon Endo-Surgery, LLC - Decided: Apr 13, 2023 after 58 days - Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories) - Device class: 2 - Regulation: 21 CFR 878.4400 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 9 generations back to K932293 (1994). 23 ancestors in all. No later device cites it as a predicate yet. 0 of 24 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K201066: ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length, Ethicon Endo-Surgery, LLC (2021) Summary page 4. - K201696: ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length, Ethicon Endo-Surgery, LLC (2021) Summary page 4. ## Indications for use The ENSEAL X1 Curved Jaw and ENSEAL X1 Straight Jaw Tissue Sealers are bipolar electrosurgical instruments for use with an electrosurgical generator. They are indicated for use during open or laparoscopic surgery. Indications for use include open and laparoscopic general surgical procedures (including bowel resections, gynecology, gastric, urologic and thoracic surgical procedures) where vessel ligation (sealing and cutting), division of lymphatics, tissue grasping and dissection is performed. The devices can be used on vessels and vascular bundles up to and including 7 mm in diameter. Source page: https://510kreport.com/device/K230387 Methodology: https://510kreport.com/methodology