510(k) · Cleared
ClearedEthicon Endo-Surgery Enseal G2 Cordless Tissue Sealers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Surgery, LLC · PDG Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.
Cleared on Mar 8, 2013 as substantially equivalent to K072177 (Surgrx, Inc., 2007) and 1 other predicate after a 144-day review. Its family tree reaches back 1 generation to 2007.
- Decided
- Mar 8, 2013
- Review
- 144 days
- Class
- Class II
- Product code
- PDG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K072177 (2007). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK072177 Enseal Vessel Sealing and Hemostasis SystemSurgrx, Inc. · 2007 · Recalled
- This deviceK123212 Ethicon Endo-Surgery Enseal G2 Cordless Tissue SealersEthicon Endo-Surgery, LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K072177 | Enseal Vessel Sealing and Hemostasis System | Surgrx, Inc. | 2007 | 1 |
| 0 (this device) | K123212 | Ethicon Endo-Surgery Enseal G2 Cordless Tissue Sealers | 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 PDG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K072177 | Enseal Vessel Sealing and Hemostasis SystemSummary page 1…PDG) * Electrocautery, Gynecologic and Accessories (21 CFR 884.4120, Product Code HUT) Predicate Devices ENSEAL Vessel Sealing and Hemnostasis System cleared under K072 177 on August 29, 2007 and K072493 cleared on September 5, 2007. The ENSEAL Vessel Sealing and Hemostasis System include ENSEAL Bipol… | 2007 |
| * | K072493 | Enseal Tissue Sealing DeviceSummary page 1…ologic and Accessories (21 CFR 884.4120, Product Code HUT) Predicate Devices ENSEAL Vessel Sealing and Hemnostasis System cleared under K072 177 on August 29, 2007 and K072493 cleared on September 5, 2007. The ENSEAL Vessel Sealing and Hemostasis System include ENSEAL Bipolar Electrosurgical Sealing Devi… | 2007 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 5 other devices also cite its predicate K072177.
How does its category compare?
All PDG devicesPDG Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · PDG
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · PDG
Too few PDG 510(k)s in any year since 2007 to give a median.
Recalls per year · PDG
No recall names PDG since 2007.
Adverse event reports per year · PDG
1in 2020
MAUDE reports naming product code PDG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (129 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123212 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123212: Ethicon Endo-Surgery Enseal G2 Cordless Tissue Sealers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123212
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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