510(k) · Cleared
ClearedEndopath Electrosurgery Probe Plus II
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 Apr 28, 2016 as substantially equivalent to K912492 (ETHICON, Inc., 1991) after a 99-day review. Its family tree reaches back 1 generation to 1991. 2 later devices descend from it.
- Decided
- Apr 28, 2016
- Review
- 99 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K912492 (1991). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK912492 Evacuation/Irrigation/Elecrosurgical DeviceETHICON, Inc. · 1991 · Recalled
- This deviceK160128 Endopath Electrosurgery Probe Plus IIEthicon Endo-Surgery, LLC · 2016
- Descendant · cites it directly · 0 of its ownK250400 Vigeon Laparoscopic Universal Smoke Evacuator (VG003)Vigeon Technology Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK180031 Endopath Electrosurgery Probe Plus IIEthicon Endo-Surgery, LLC · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912492 | Evacuation/Irrigation/Elecrosurgical Device | ETHICON, Inc. | 1991 | 22 |
| 0 (this device) | K160128 | Endopath Electrosurgery Probe Plus II | Ethicon Endo-Surgery, LLC | 2016 | — |
| +1 | K250400 | Vigeon Laparoscopic Universal Smoke Evacuator (VG003) | Vigeon Technology Co., Ltd. | 2025 | — |
| +1 | K180031 | Endopath Electrosurgery Probe Plus II | Ethicon Endo-Surgery, LLC | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K912492 | Evacuation/Irrigation/Elecrosurgical DeviceSummary page 4…S07 Device Class Class II Device Panel General & Plastic Surgery Product Code GEI Predicate Device Ethicon Evacuation/Irrigation/Electrosurgical Device cleared under K912492 Device Description The Endopath® Electrosurgery Probe Plus II device (product codes beginning with EPH and EPS) work with a stan… | 1991 |
What descends from it? (2)
2 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?
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 ENDOPATH Electrosurgery Probe Plus II system has application in minimally invasive procedures to facilitate tissue dissection, coagulation, irrigation, and fluid evacuation through a common trocar sleeve.
Contraindications
• These instruments are not intended for contraceptive coagulation of fallopian tissue but may be used to achieve hemostasis following transection of the fallopian tube.
• These instruments are not intended for use when minimally invasive techniques are contraindicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160128 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160128: Endopath Electrosurgery Probe Plus II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160128
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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