510(k) · Cleared
ClearedThe ETHICON™ Total Energy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company) · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jan 17, 2025 as substantially equivalent to K200841 (Ethicon Endo-Surgery, LLC, 2020) and 1 other predicate after a 112-day review. Its family tree reaches back 11 generations to 1994.
- Decided
- Jan 17, 2025
- Review
- 112 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K932293 (1994). 70 ancestors in all, the oldest K852143 (1985). No later device cites it as a predicate yet.
- Root · 11 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 7 generations between
- 3 generations backK141122 Harmonic Scallop Blade, Generator G11Ethicon Endo-Surgery, LLC · 2014
- 2 generations backK160554 Enseal X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC · 2016
- 1 generation backK200841 Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length…Ethicon Endo-Surgery, LLC · 2020
- This deviceK243067 The ETHICON™ Total Energy SystemEthicon Endo-Surgery, LLC (A Johnson and Johnson Company) · 2025
Show all 11 generations
- Root · 11 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 10 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 9 generations backK031133 Surgrx Enseal Vessel Sealing and Hemostasis System Including the…Surgrx, Inc. · 2003
- 8 generations backK061526 Enseal PTC Tissue Sealing DeviceSurgrx, Inc. · 2006
- 7 generations backK062949 Enseal PTC Tissue Seating Sealing DeviceSurgrx, Inc. · 2006
- 6 generations backK070165 Enseal PTC TrioSurgrx, Inc. · 2007 · Recalled
- 5 generations backK081129 Enseal…Surgrx, Inc. · 2008
- 4 generations backK101990 Ethicon Endo-Surgery Generator G11, Model GEN11Ethicon Endo-Sugery, LLC · 2011
- 3 generations backK141122 Harmonic Scallop Blade, Generator G11Ethicon Endo-Surgery, LLC · 2014
- 2 generations backK160554 Enseal X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC · 2016
- 1 generation backK200841 Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length…Ethicon Endo-Surgery, LLC · 2020
- This deviceK243067 The ETHICON™ Total Energy SystemEthicon Endo-Surgery, LLC (A Johnson and Johnson Company) · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −10 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −9 | K031133 | Surgrx Enseal Vessel Sealing and Hemostasis System Including the Enseal… | Surgrx, Inc. | 2003 | — |
| −8 | K061526 | Enseal PTC Tissue Sealing Device | Surgrx, Inc. | 2006 | — |
| −7 | K062949 | Enseal PTC Tissue Seating Sealing Device | Surgrx, Inc. | 2006 | — |
| −6 | K070165 | Enseal PTC Trio | Surgrx, Inc. | 2007 | 1 |
| −5 | K081129 | Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD… | Surgrx, Inc. | 2008 | — |
| −4 | K101990 | Ethicon Endo-Surgery Generator G11, Model GEN11 | Ethicon Endo-Sugery, LLC | 2011 | — |
| −3 | K141122 | Harmonic Scallop Blade, Generator G11 | Ethicon Endo-Surgery, LLC | 2014 | — |
| −2 | K160554 | Enseal X1 Large Jaw Tissue Sealer | Ethicon Endo-Surgery, LLC | 2016 | — |
| −1 | K200841 | Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 | Ethicon Endo-Surgery, LLC | 2020 | — |
| 0 (this device) | K243067 | The ETHICON™ Total Energy System | Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company) | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 9 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 5 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2020 | 2 | 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? (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 |
|---|---|---|---|
| * | K200841 | Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11Summary page 9…Delivered (Decision Date) Ethicon Endo-Surgery Ultrasonic GEN11 K200841 (11 May 2020) Generator G11 Advanced Bipolar Ethicon Megadyne MEGEN1 Mono… | 2020 |
| * | K193145 | Ethicon Megadyne Electrosurgical Generator, Bipolar FootswitchSummary page 9…K200841 (11 May 2020) Generator G11 Advanced Bipolar Ethicon Megadyne MEGEN1 Monopolar/ Bipolar K193145 (24 Mar 2020) Electrosurgical Generator… | 2020 |
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 31 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 14 of the 70 ancestors have a recall of any class.
- 3 other devices also cite its predicate K200841.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 ETHICON™ Total Energy System is an electrosurgical generator that provides power to monopolar, bipolar, and ultrasonic surgical instruments. It is indicated for surgical procedures requiring cutting or coagulation of soft tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243067 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243067: The ETHICON™ Total Energy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243067
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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