# K112033: Enseal G2 Tissus Sealers

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Sugery, LLC
- Decided: Nov 8, 2011 after 116 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 5 (0 Class I)
- 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.
76 later devices descend from it; 7 cite it directly.
0 of 79 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.

## Most influential descendants
- K123444: Ligasure Impact Curved, Large Jaw, Open Sealer / Divider (2013), 56 descendants of its own
- K141153: Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider, Maryland Jaw One Step Stealer/Dividers, Curved (2014), 40 descendants of its own
- K132612: Harmonic Ace+ Shears 23 CM Length with Advanced Hemostasis, Harmonic Ace + Laparoscopic Shears 36 CM Length with Advance (2013), 16 descendants of its own
- K152286: LigaSure Curved, Small Jaw, Open Sealer/Divider (2015), 14 descendants of its own
- K170869: LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated (2017), 11 descendants of its own

## Recalls of this device
- Nov 6, 2012 · Class II · Z-0758-2013: Potential for self activation while the device is in use, which may result in unintended thermal damage.
- Jan 26, 2012 · Not classified · Z-1245-2012: Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENSEAL G2 Curved and Straight Tissue Sealers due to two potential issues that may occur related to the activati
- Jan 26, 2012 · Not classified · Z-1244-2012: Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENSEAL G2 Curved and Straight Tissue Sealers due to two potential issues that may occur related to the activati
- Jan 26, 2012 · Not classified · Z-1246-2012: Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENSEAL G2 Curved and Straight Tissue Sealers due to two potential issues that may occur related to the activati
- Jan 26, 2012 · Not classified · Z-1247-2012: Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENSEAL G2 Curved and Straight Tissue Sealers due to two potential issues that may occur related to the activati

## Indications for use
The ENSEAL® G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. The devices are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic, general and gynecological surgery to cut and seal vessels, and to cut, grasp and dissect tissue during surgery. Indications for use include open and laparoscopic, general and gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectornies, 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 mum and bundles as large as will fit in the jaws of the instruments. The ENS EALO 02 Tissue Sealers have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use these devices for these procedures.

Source page: https://510kreport.com/device/K112033
Methodology: https://510kreport.com/methodology