510(k) · Cleared
ClearedEthicon Endo-Surgery Generator G11, Model GEN11
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Sugery, LLC · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jun 13, 2011 as substantially equivalent to K072177 (Surgrx, Inc., 2007) and 2 other predicates after a 333-day review. Its family tree reaches back 7 generations to 1994. 11 later devices descend from it.
- Decided
- Jun 13, 2011
- Review
- 333 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K932293 (1994). 28 ancestors in all, the oldest K904560 (1990). 11 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 6 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 5 generations backK031133 Surgrx Enseal Vessel Sealing and Hemostasis System Including the…Surgrx, Inc. · 2003
- 4 generations backK061526 Enseal PTC Tissue Sealing DeviceSurgrx, Inc. · 2006
- 3 generations backK062949 Enseal PTC Tissue Seating Sealing DeviceSurgrx, Inc. · 2006
- 2 generations backK070165 Enseal PTC TrioSurgrx, Inc. · 2007 · Recalled
- 1 generation backK081129 Enseal…Surgrx, Inc. · 2008
- This deviceK101990 Ethicon Endo-Surgery Generator G11, Model GEN11Ethicon Endo-Sugery, LLC · 2011
- Descendant · cites it directly · 9 of its ownK141122 Harmonic Scallop Blade, Generator G11Ethicon Endo-Surgery, LLC · 2014
- Descendant · 2 generations on · 6 of its ownK160554 Enseal X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC · 2016
- Descendant · 3 generations on · 4 of its ownK200841 Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length…Ethicon Endo-Surgery, LLC · 2020
- Descendant · 4 generations on · 1 of its ownK233471 Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length…Stryker Sustainability Solutions · 2024
- Descendant · 2 generations on · 1 of its ownK212614 Ultrasonic Scalpel SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd. · 2022
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K141122Harmonic Scallop Blade, Generator G11Ethicon Endo-Surgery, LLC · 2014 · cites it directly9descendants
- K160554Enseal X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC · 2016 · 2 generations on6descendants
- K200841Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11Ethicon Endo-Surgery, LLC · 2020 · 3 generations on4descendants
- K233471Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed…Stryker Sustainability Solutions · 2024 · 4 generations on1descendant
- K212614Ultrasonic Scalpel SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd. · 2022 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −6 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −5 | K031133 | Surgrx Enseal Vessel Sealing and Hemostasis System Including the Enseal… | Surgrx, Inc. | 2003 | — |
| −4 | K061526 | Enseal PTC Tissue Sealing Device | Surgrx, Inc. | 2006 | — |
| −3 | K062949 | Enseal PTC Tissue Seating Sealing Device | Surgrx, Inc. | 2006 | — |
| −2 | K070165 | Enseal PTC Trio | Surgrx, Inc. | 2007 | 1 |
| −1 | K081129 | Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD… | Surgrx, Inc. | 2008 | — |
| 0 (this device) | K101990 | Ethicon Endo-Surgery Generator G11, Model GEN11 | Ethicon Endo-Sugery, LLC | 2011 | — |
| +1 | K141122 | Harmonic Scallop Blade, Generator G11 | Ethicon Endo-Surgery, LLC | 2014 | — |
| +2 | K160554 | Enseal X1 Large Jaw Tissue Sealer | Ethicon Endo-Surgery, LLC | 2016 | — |
| +3 | K200841 | Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 | Ethicon Endo-Surgery, LLC | 2020 | — |
| +4 | K233471 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120)… | Stryker Sustainability Solutions | 2024 | — |
| +2 | K212614 | Ultrasonic Scalpel System | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (3)
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…84.4120, Product Code HGI) *Instrument, Ultrasonic Surgical (Unassigned, Product Code LFL) Predicate Devices " EnSeal®o RF60 Electrosurgzical Generator (cleared under K072 177 on September 5, 2007 as part of the EnSeal® Vessel Sealing and Hemostasis System) * EnSeal®'Universal Generator (cleared under… | 2007 |
| * | K081129 | Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD…Summary page 1…gzical Generator (cleared under K072 177 on September 5, 2007 as part of the EnSeal® Vessel Sealing and Hemostasis System) * EnSeal®'Universal Generator (cleared under K08 1129 on July 28, 2008 as a system with the EnSeal PowerTip instrument) " Ultraision Harmonic® Scalpel Generator 300 (cleared under K… | 2008 |
| * | K002906 | Ultracision Harmonic Scalpel System, Models GEN01, GEN02, GEN03, HP052, HP053, HSA07Summary page 1…iversal Generator (cleared under K08 1129 on July 28, 2008 as a system with the EnSeal PowerTip instrument) " Ultraision Harmonic® Scalpel Generator 300 (cleared under K002906 on December 15, 2000 as part of the Ultraision Harmonic®' Scalpel Generator 300 System) Device Description: The Ethicon Endo-… | 2000 |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 7 of the 28 ancestors have a recall of any class.
- Of its descendants, K141122 (Ethicon Endo-Surgery, LLC, 2014) has gone furthest, with 9 descendants of its own.
- 5 other devices also cite its predicate K072177.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Generator GIII provides radiofrequency power to drive EnSeal® electrosurgical instruments that are used during open or laparoscopic general and gynecological surgery to cut and seal vessels and to cut, grasp, and dissect tissue. In addition the generator provides power to drive Harmonic® ultrasonic surgical instruments that are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.
EnSeal® and Harmonic® instruments when used with the Generator GIII have not been shown to be effective for sterilization procedures or tubal coagulation. Do not use these instruments for these procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101990 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101990: Ethicon Endo-Surgery Generator G11, Model GEN11.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101990
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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