510(k) · Cleared
ClearedEnseal G2 Articulating Tissue Sealers, Straight Jaw, Enseal G2 Articulating Tissue Sealers, Curved Jaw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Surgery, LLC · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jan 25, 2013 as substantially equivalent to K112033 (Ethicon Endo-Sugery, LLC, 2011) after a 135-day review. Its family tree reaches back 2 generations to 2007.
- Decided
- Jan 25, 2013
- Review
- 135 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K072177 (2007). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK072177 Enseal Vessel Sealing and Hemostasis SystemSurgrx, Inc. · 2007 · Recalled
- 1 generation backK112033 Enseal G2 Tissus SealersEthicon Endo-Sugery, LLC · 2011 · Recalled
- This deviceK122797 Enseal G2 Articulating Tissue Sealers, Straight Jaw, Enseal G2…Ethicon Endo-Surgery, LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K072177 | Enseal Vessel Sealing and Hemostasis System | Surgrx, Inc. | 2007 | 1 |
| −1 | K112033 | Enseal G2 Tissus Sealers | Ethicon Endo-Sugery, LLC | 2011 | 5 |
| 0 (this device) | K122797 | Enseal G2 Articulating Tissue Sealers, Straight Jaw, Enseal G2 Articulating… | Ethicon Endo-Surgery, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K112033 | Enseal G2 Tissus Sealers | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 6 other devices also cite its predicate K112033.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The ENSEAL® G2 Articulating 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 the Generator GEN II (GEN 11). 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…
Read the full statement (166 words)
The ENSEAL® G2 Articulating 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 the Generator GEN II (GEN 11). 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, 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) 7mm and tissue and/or vascular bundles as large as will fit in the jaws of the instruments.
The ENSEAL® G2 Articulating 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122797 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122797: Enseal G2 Articulating Tissue Sealers, Straight Jaw, Enseal G2 Articulating Tissue Sealers, Curved Jaw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122797
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026