510(k) · Cleared
ClearedEndopath Endoscopic Electrosurgical Forceps with Cutting Feature
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 4, 1994 after a 150-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Mar 4, 1994
- Review
- 150 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK934784 Endopath Endoscopic Electrosurgical Forceps with Cutting FeatureETHICON, Inc. · 1994
- Descendant · cites it directly · 2 of its ownK012625 Reprocessed Unipolar Laparoscopic/Endoscopic InstrumentsAlliance Medical Corp. · 2001
- Descendant · 2 generations on · 0 of its ownK240334 LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D…Lagis Enterprise Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK031869 Siss Inc. (D.B.a. Medisiss) Reprocessed Electrosurgical Instruments…Surgical Instruments Service and Savings, Inc. · 2003
Most influential descendants
Showing 3 of 3 · See all- K012625Reprocessed Unipolar Laparoscopic/Endoscopic InstrumentsAlliance Medical Corp. · 2001 · cites it directly2descendants
- K240334LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D…Lagis Enterprise Co., Ltd. · 2024 · 2 generations on0descendants
- K031869Siss Inc. (D.B.a. Medisiss) Reprocessed Electrosurgical Instruments and AccessoriesSurgical Instruments Service and Savings, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934784 | Endopath Endoscopic Electrosurgical Forceps with Cutting Feature | ETHICON, Inc. | 1994 | — |
| +1 | K012625 | Reprocessed Unipolar Laparoscopic/Endoscopic Instruments | Alliance Medical Corp. | 2001 | — |
| +2 | K240334 | LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D… | Lagis Enterprise Co., Ltd. | 2024 | — |
| +1 | K031869 | Siss Inc. (D.B.a. Medisiss) Reprocessed Electrosurgical Instruments and… | Surgical Instruments Service and Savings, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
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?
- Of its descendants, K012625 (Alliance Medical Corp., 2001) has gone furthest, with 2 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K934784 · printed Nov 4, 2026
Cite this page
510(k) Report. “K934784: Endopath Endoscopic Electrosurgical Forceps with Cutting Feature.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K934784
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026