510(k) · Cleared
ClearedEnseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, Etrio-314D,-325D,-335D,-345D, Enseal Universal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgrx, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jul 28, 2008 as substantially equivalent to K031133 (Surgrx, Inc., 2003) and 12 other predicates after a 98-day review. Its family tree reaches back 6 generations to 1994. 24 later devices descend from it.
- Decided
- Jul 28, 2008
- Review
- 98 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 13
Its longest line of descent runs back 6 generations to K932293 (1994). 26 ancestors in all, the oldest K904560 (1990). 24 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 5 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 4 generations backK031133 Surgrx Enseal Vessel Sealing and Hemostasis System Including the…Surgrx, Inc. · 2003
- 3 generations backK061526 Enseal PTC Tissue Sealing DeviceSurgrx, Inc. · 2006
- 2 generations backK062949 Enseal PTC Tissue Seating Sealing DeviceSurgrx, Inc. · 2006
- 1 generation backK070165 Enseal PTC TrioSurgrx, Inc. · 2007 · Recalled
- This deviceK081129 Enseal…Surgrx, Inc. · 2008
- Descendant · cites it directly · 11 of its ownK111202 Surgical Tissue Management SystemOlympus Medical Systems Corp. · 2012 · Recalled
- Descendant · cites it directly · 11 of its ownK101990 Ethicon Endo-Surgery Generator G11, Model GEN11Ethicon Endo-Sugery, LLC · 2011
- Descendant · 2 generations on · 9 of its ownK141122 Harmonic Scallop Blade, Generator G11Ethicon Endo-Surgery, LLC · 2014
- Descendant · 2 generations on · 9 of its ownK132703 ThunderbeatOlympus Medical Systems Corp. · 2014
- Descendant · 3 generations on · 6 of its ownK160554 Enseal X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC · 2016
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K111202Surgical Tissue Management SystemOlympus Medical Systems Corp. · 2012 · cites it directly11descendants
- K101990Ethicon Endo-Surgery Generator G11, Model GEN11Ethicon Endo-Sugery, LLC · 2011 · cites it directly11descendants
- K141122Harmonic Scallop Blade, Generator G11Ethicon Endo-Surgery, LLC · 2014 · 2 generations on9descendants
- K132703ThunderbeatOlympus Medical Systems Corp. · 2014 · 2 generations on9descendants
- K160554Enseal X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC · 2016 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −5 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −4 | K031133 | Surgrx Enseal Vessel Sealing and Hemostasis System Including the Enseal… | Surgrx, Inc. | 2003 | — |
| −3 | K061526 | Enseal PTC Tissue Sealing Device | Surgrx, Inc. | 2006 | — |
| −2 | K062949 | Enseal PTC Tissue Seating Sealing Device | Surgrx, Inc. | 2006 | — |
| −1 | K070165 | Enseal PTC Trio | Surgrx, Inc. | 2007 | 1 |
| 0 (this device) | K081129 | Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD… | Surgrx, Inc. | 2008 | — |
| +1 | K111202 | Surgical Tissue Management System | Olympus Medical Systems Corp. | 2012 | 10 |
| +1 | K101990 | Ethicon Endo-Surgery Generator G11, Model GEN11 | Ethicon Endo-Sugery, LLC | 2011 | — |
| +2 | K141122 | Harmonic Scallop Blade, Generator G11 | Ethicon Endo-Surgery, LLC | 2014 | — |
| +2 | K132703 | Thunderbeat | Olympus Medical Systems Corp. | 2014 | — |
| +3 | K160554 | Enseal X1 Large Jaw Tissue Sealer | Ethicon Endo-Surgery, LLC | 2016 | — |
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 |
| 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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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? (13)
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 |
|---|---|---|---|
| * | K031133 | Surgrx Enseal Vessel Sealing and Hemostasis System Including the Enseal Controller…Summary page 1…section 878.4400) and Gynecologic Electrocautery and Accessories (per 21 CFR 884.4120). 3. Predicate Devices EnSeal Vessel Sealing and Hemostasis System: k031133, k043008, k050671, k061526, k062949, k063097, k070165, k070896, k072177, k072493, LigaSure Advance: k063195, Gyru… | 2003 |
| * | K043008 | Surgrx Enseal Vessel Sealing & Hemostasis SystemSummary page 1…878.4400) and Gynecologic Electrocautery and Accessories (per 21 CFR 884.4120). 3. Predicate Devices EnSeal Vessel Sealing and Hemostasis System: k031133, k043008, k050671, k061526, k062949, k063097, k070165, k070896, k072177, k072493, LigaSure Advance: k063195, Gyrus Bipolar… | 2004 |
| * | K050671 | Enseal Vessel Sealing & Hemostasis SystemSummary page 1…and Gynecologic Electrocautery and Accessories (per 21 CFR 884.4120). 3. Predicate Devices EnSeal Vessel Sealing and Hemostasis System: k031133, k043008, k050671, k061526, k062949, k063097, k070165, k070896, k072177, k072493, LigaSure Advance: k063195, Gyrus Bipolar Needle E… | 2005 |
| * | K061526 | Enseal PTC Tissue Sealing DeviceSummary page 1…Electrocautery and Accessories (per 21 CFR 884.4120). 3. Predicate Devices EnSeal Vessel Sealing and Hemostasis System: k031133, k043008, k050671, k061526, k062949, k063097, k070165, k070896, k072177, k072493, LigaSure Advance: k063195, Gyrus Bipolar Needle Electrode: k031079… | 2006 |
| * | K062949 | Enseal PTC Tissue Seating Sealing DeviceSummary page 1…utery and Accessories (per 21 CFR 884.4120). 3. Predicate Devices EnSeal Vessel Sealing and Hemostasis System: k031133, k043008, k050671, k061526, k062949, k063097, k070165, k070896, k072177, k072493, LigaSure Advance: k063195, Gyrus Bipolar Needle Electrode: k031079, ValleyL… | 2006 |
| * | K063097 | Enseal PTC Tissue Sealing DeviceSummary page 1…Accessories (per 21 CFR 884.4120). 3. Predicate Devices EnSeal Vessel Sealing and Hemostasis System: k031133, k043008, k050671, k061526, k062949, k063097, k070165, k070896, k072177, k072493, LigaSure Advance: k063195, Gyrus Bipolar Needle Electrode: k031079, ValleyLab ForceT… | 2006 |
| * | K070165 | Enseal PTC TrioSummary page 1…ies (per 21 CFR 884.4120). 3. Predicate Devices EnSeal Vessel Sealing and Hemostasis System: k031133, k043008, k050671, k061526, k062949, k063097, k070165, k070896, k072177, k072493, LigaSure Advance: k063195, Gyrus Bipolar Needle Electrode: k031079, ValleyLab ForceTriad:… | 2007 |
| * | K070896 | Enseal PTC Tissue Sealing DeviceSummary page 1…21 CFR 884.4120). 3. Predicate Devices EnSeal Vessel Sealing and Hemostasis System: k031133, k043008, k050671, k061526, k062949, k063097, k070165, k070896, k072177, k072493, LigaSure Advance: k063195, Gyrus Bipolar Needle Electrode: k031079, ValleyLab ForceTriad: k051… | 2007 |
| * | K072177 | Enseal Vessel Sealing and Hemostasis SystemSummary page 1…CFR 884.4120). 3. Predicate Devices EnSeal Vessel Sealing and Hemostasis System: k031133, k043008, k050671, k061526, k062949, k063097, k070165, k070896, k072177, k072493, LigaSure Advance: k063195, Gyrus Bipolar Needle Electrode: k031079, ValleyLab ForceTriad: k051644. 4. D… | 2007 |
| * | K072493 | Enseal Tissue Sealing DeviceSummary page 1…4120). 3. Predicate Devices EnSeal Vessel Sealing and Hemostasis System: k031133, k043008, k050671, k061526, k062949, k063097, k070165, k070896, k072177, k072493, LigaSure Advance: k063195, Gyrus Bipolar Needle Electrode: k031079, ValleyLab ForceTriad: k051644. 4. Device Des… | 2007 |
| * | K063195 | Ligasure Advance Laparoscopic Sealer/Divider with Dissecting Electrode, Models LF5034…Summary page 1…EnSeal Vessel Sealing and Hemostasis System: k031133, k043008, k050671, k061526, k062949, k063097, k070165, k070896, k072177, k072493, LigaSure Advance: k063195, Gyrus Bipolar Needle Electrode: k031079, ValleyLab ForceTriad: k051644. 4. Device Description EnSeal PowerTip wit… | 2006 |
| * | K031079 | Everest Bipolar Needle Electrode & Gyrus Bipolar Needle ElectrodeSummary page 1…tem: k031133, k043008, k050671, k061526, k062949, k063097, k070165, k070896, k072177, k072493, LigaSure Advance: k063195, Gyrus Bipolar Needle Electrode: k031079, ValleyLab ForceTriad: k051644. 4. Device Description EnSeal PowerTip with EnSeal Universal. The functionality of… | 2003 |
| * | K051644 | Valleylab Forcetriad Electrosurgical GeneratorSummary page 1…k061526, k062949, k063097, k070165, k070896, k072177, k072493, LigaSure Advance: k063195, Gyrus Bipolar Needle Electrode: k031079, ValleyLab ForceTriad: k051644. 4. Device Description EnSeal PowerTip with EnSeal Universal. The functionality of the devices are the same as the… | 2005 |
What descends from it? (24)
See all 242 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 14 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 7 of the 26 ancestors have a recall of any class.
- Of its descendants, K111202 (Olympus Medical Systems Corp., 2012) has gone furthest, with 11 descendants of its own.
- 5 other devices also cite its predicate K031133.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 PowerTip is an electrosurgical instrument for use with the EnSeal Universal electrosurgical generator. It is intended for use during open or laparoscopic, general and gynecologic surgery to cut and seal vessels, 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…
Read the full statement (158 words)
The EnSeal PowerTip is an electrosurgical instrument for use with the EnSeal Universal electrosurgical generator. It is intended for use during open or laparoscopic, general and gynecologic surgery to cut and seal vessels, 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), 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 mm and bundles as large as will fit in the jaws of the instruments.
The cutting tip feature is intended for use in the dissection of tissue planes and the creation of enterotomies and gastrotomies.
The EnSeal PowerTip 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/K081129 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081129: Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, Etrio-314D,-325D,-335D,-345D, Enseal Universal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081129
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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