510(k) · Cleared
Recalled · 2007Endopath Endoscopic Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Surgery, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jun 22, 1999 as substantially equivalent to K910831 (Symbiosis Corp., 1991) after a 207-day review. Its family tree reaches back 1 generation to 1991. 38 later devices descend from it. It has been recalled once.
- Decided
- Jun 22, 1999
- Review
- 207 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K910831 (1991). 38 later devices descend from it, 13 citing it directly.
- Root · 1 generation backK910831 Endopath Surgical InstrumentsSymbiosis Corp. · 1991
- This deviceK984240 Endopath Endoscopic InstrumentsEthicon Endo-Surgery, Inc. · 1999
- Descendant · cites it directly · 14 of its ownK061425 Purewrist Scissors, Model PW1101-01;Purewrist Dissector, Model…Cambridge Endoscopic Devices · 2006 · Recalled
- Descendant · 2 generations on · 8 of its ownK173919 HX DeviceHuman Extension, Ltd. · 2018
- Descendant · cites it directly · 6 of its ownK061417 Genicon Disposable Electrosurgical Instrumentation, Model 533-005-910Genicon · 2006
- Descendant · cites it directly · 4 of its ownK043541 Endolink True Movement SystemNovare Surgical Systems, Inc. · 2005
- Descendant · 3 generations on · 3 of its ownK203603 Monopolar HookHuman Xtensions, Ltd. · 2021
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K061425Purewrist Scissors, Model PW1101-01;Purewrist Dissector, Model PW1201-01;Purewrist Hook…Cambridge Endoscopic Devices · 2006 · cites it directly14descendants
- K173919HX DeviceHuman Extension, Ltd. · 2018 · 2 generations on8descendants
- K061417Genicon Disposable Electrosurgical Instrumentation, Model 533-005-910Genicon · 2006 · cites it directly6descendants
- K043541Endolink True Movement SystemNovare Surgical Systems, Inc. · 2005 · cites it directly4descendants
- K203603Monopolar HookHuman Xtensions, Ltd. · 2021 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910831 | Endopath Surgical Instruments | Symbiosis Corp. | 1991 | — |
| 0 (this device) | K984240 | Endopath Endoscopic Instruments | Ethicon Endo-Surgery, Inc. | 1999 | — |
| +1 | K061425 | Purewrist Scissors, Model PW1101-01;Purewrist Dissector, Model… | Cambridge Endoscopic Devices | 2006 | 2 |
| +2 | K173919 | HX Device | Human Extension, Ltd. | 2018 | — |
| +1 | K061417 | Genicon Disposable Electrosurgical Instrumentation, Model 533-005-910 | Genicon | 2006 | — |
| +1 | K043541 | Endolink True Movement System | Novare Surgical Systems, Inc. | 2005 | — |
| +3 | K203603 | Monopolar Hook | Human Xtensions, Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 5 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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? (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 |
|---|---|---|---|
| * | K910831 | Endopath Surgical InstrumentsSummary page 1…cessories o Common Name: Laparoscopic Surgical Instruments ¢ Trade Name/Proprietary Name: ENDOPATH® Endoscopic Instruments The Predicate Device legally marketed under K910831: {Symbiosis] ENDOPATH Endoscopic Instruments The ENDOPATH Endoscopic Instruments are sterile, single patient use instruments des… | 1991 |
What descends from it? (38)
See all 3813 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061425 | Purewrist Scissors, Model PW1101-01;Purewrist Dissector, Model PW1201-01;Purewrist Hook… | 2006 | 14 |
| K061417 | Genicon Disposable Electrosurgical Instrumentation, Model 533-005-910 | 2006 | 6 |
| K043541 | Endolink True Movement System | 2005 | 4 |
| K103282 | Laparoscopic Dissector | 2010 | 2 |
| K012625 | Reprocessed Unipolar Laparoscopic/Endoscopic Instruments | 2001 | 2 |
| K193019 | DANNIK Disposable Monopolar Laparoscopic Instrument | 2020 | 1 |
| K072715 | Realhand High Dexterity Instruments | 2007 | 1 |
| K012598 | Reprocessed Laparoscopic Electric Instuments | 2001 | 1 |
| K253134 | LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T) | 2026 | 0 |
| K201063 | DANNIK Disposable Monopolar Laparoscopic Instrument | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 6, 2007 | Not classified | Z-0565-2008 | Process control | Sterility (package integrity) compromised; Damaged packaging may have compromised the sterility of the devices. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K061425 (Cambridge Endoscopic Devices, 2006) has gone furthest, with 14 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 | — |
What is it indicated for?
The ENDOPATH Endoscopic Instruments have application in a variety of
minimally invasive procedures to facilitate grasping, mobilization, dissection
and transection of tissue.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984240 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984240: Endopath Endoscopic Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984240
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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