# K123212: Ethicon Endo-Surgery Enseal G2 Cordless Tissue Sealers

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, LLC
- Decided: Mar 8, 2013 after 144 days
- Product code: PDG (Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.)
- 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). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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.
- K072493: Enseal Tissue Sealing Device, Surgrx, Inc. (2007) Summary page 1.

## Indications for use
The Ethicon Endo-Surgery ENSEAL® G2 Cordless Curved Jaw Tissue Sealers are intended for use during open or laparoscopic, general and gynecological surgery to cut and seal vessels, cut, grasp and dissect tissue during surgery. Indications for use include open and laparoscopic 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 are performed. The devices can be used on vessels up to (and including) 7mm and bundles as large as will fit in the jaws of the instruments. The 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/K123212
Methodology: https://510kreport.com/methodology