# K101520: Enseal Tissue Sealing Devices Model: NSEAL514H-535H, NSEAL514RH-535RH

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Dec 10, 2010 after 191 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: 1 generation back to K072177 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072177: Enseal Vessel Sealing and Hemostasis System, Surgrx, Inc. (2007) Summary page 1.

## Indications for use
The EnSeal LCJ Tissue Sealing Device is indicated for bipolar coagulation and mechanical transection of tissue during open procedures. It is a bipolar electrosurgical instrument for use with an electrosurgical generator. It is intended for use during open, general and gynecological surgery to cut and seal vessels, cut, grasp and dissect tissue during surgery. Indications for use include open, general, gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. 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 Tissue Sealing Device has 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/K101520
Methodology: https://510kreport.com/methodology