# K172580: ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length, 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

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, LLC
- Decided: Nov 20, 2017 after 84 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K932293 (1994). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112033: Enseal G2 Tissus Sealers, Ethicon Endo-Sugery, LLC (2011) Summary page 4.
- K131435: Enseal G2 Tissue Sealer, Straight Jaw, Enseal G2 Tissue Sealer, Curved Jaw, Enseal Trio Tissue Sealer, 3 MM Curved Jaw,, Ethicon Endo-Surgery, LLC (2013) Summary page 4.

## Recalls of this device
- May 15, 2019 · Class II · Z-1889-2019: Observed reported incidence rate for harm associated with intraoperative bleeding
- May 15, 2019 · Class II · Z-1890-2019: Observed reported incidence rate for harm associated with intraoperative bleeding
- May 15, 2019 · Class II · Z-1888-2019: Observed reported incidence rate for harm associated with intraoperative bleeding

## Indications for use
The ENSEAL X1 Tissue Sealers are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic surgical procedures to cut and seal vessels, and to cut, grasp and dissect tissue during surgery. Indications for use include open and laparoscopic general, gynecological, urologic, thoracic, plastic and reconstructive, and ENT surgical procedures or any procedure where vessel ligation (cutting and sealing), tissue grasping, dissection, and division of vessels, lymphatics, and tissue bundles is performed (e.g. bowel resections, hysterectomies, gall bladder procedures, Nissen Fundoplication, adhesiolysis, and oophorectomies). The devices can be used on vessels up to and including 7 mm and bundles as large as will fit in the jaws of the instruments. The ENSEAL X1 Tissue Sealers have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.

Source page: https://510kreport.com/device/K172580
Methodology: https://510kreport.com/methodology