510(k) · Cleared
Recalled · 2003Endopath Ets Linear/Ets-Flex Articulating Linear Endoscopic Cutter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Surgery, Inc. · OCW Endoscopic Tissue Approximation Device
Cleared on Jun 25, 1996 after a 76-day review. The FDA summary names no predicate by number. 1 of the 90 devices in its family, counting itself, has a Class I recall. 89 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 25, 1996
- Review
- 76 days
- Class
- Class II
- Product code
- OCW
- Recalls
- 2
- Predicates
- 0
89 later devices descend from it, 5 citing it directly. 1 of the 90 devices in this family, counting this one, has a Class I recall.
- This deviceK961390 Endopath Ets Linear/Ets-Flex Articulating Linear Endoscopic CutterEthicon Endo-Surgery, Inc. · 1996
- Descendant · cites it directly · 88 of its ownK980023 Endopath and Proximate Linear CuttersEthicon Endo-Surgery, Inc. · 1998
- Descendant · cites it directly · 87 of its ownK020779 Proximate and Endopath Linear Cutters and StaplersEthicon Endo-Surgery, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 46 of its ownK030653 Surgassist Straight Linear Stapler and Straight Linear 4 Row NO…Power Medical Interventions, Inc. · 2003
- Descendant · 3 generations on · 45 of its ownK040398 Surgassist Straight Linear 4 Row NO Knife Dlus with ReloadsPower Medical Interventions, Inc. · 2004
- Descendant · 4 generations on · 25 of its ownK040720 Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30…Power Medical Interventions, Inc. · 2004 · Recalled
Showing 5 of 89 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K141952 Echelon Flex Powered Vascular Stapler with…2 generations on · 2014
Most influential descendants
Showing 5 of 89 · See all- K980023Endopath and Proximate Linear CuttersEthicon Endo-Surgery, Inc. · 1998 · cites it directly88descendants
- K020779Proximate and Endopath Linear Cutters and StaplersEthicon Endo-Surgery, Inc. · 2002 · cites it directly87descendants
- K030653Surgassist Straight Linear Stapler and Straight Linear 4 Row NO Knife Digital Loading…Power Medical Interventions, Inc. · 2003 · 2 generations on46descendants
- K040398Surgassist Straight Linear 4 Row NO Knife Dlus with ReloadsPower Medical Interventions, Inc. · 2004 · 3 generations on45descendants
- K040720Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 MM, 55 MM, 75 MMPower Medical Interventions, Inc. · 2004 · 4 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961390 | Endopath Ets Linear/Ets-Flex Articulating Linear Endoscopic Cutter | Ethicon Endo-Surgery, Inc. | 1996 | — |
| +1 | K980023 | Endopath and Proximate Linear Cutters | Ethicon Endo-Surgery, Inc. | 1998 | — |
| +1 | K020779 | Proximate and Endopath Linear Cutters and Staplers | Ethicon Endo-Surgery, Inc. | 2002 | 17 |
| +2 | K030653 | Surgassist Straight Linear Stapler and Straight Linear 4 Row NO Knife Digital… | Power Medical Interventions, Inc. | 2003 | — |
| +3 | K040398 | Surgassist Straight Linear 4 Row NO Knife Dlus with Reloads | Power Medical Interventions, Inc. | 2004 | — |
| +4 | K040720 | Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 MM, 55… | Power Medical Interventions, Inc. | 2004 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 5 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 9 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 7 | 1 |
| 2015 | 3 | 0 |
| 2016 | 6 | 0 |
| 2017 | 8 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 5 | 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.
1 device in this family has a Class I recall. 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 OCW device
- #1 K252400 Endomina EZFuse systemscore 12.0 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (89)
See all 895 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980023 | Endopath and Proximate Linear Cutters | 1998 | 88 |
| K020779 | Proximate and Endopath Linear Cutters and Staplers | 2002 | 87 |
| K111111 | Endopath Ets 35MM Endoscopic Linear Cutter and Reloads, and Ets-Flex 35MM Endoscopic… | 2011 | 5 |
| K150026 | Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife… | 2015 | 0 |
| K070859 | Reprocessed Ethicon Ets Endoscopic Linear Cutters | 2007 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 25, 2003 | Not classified | Z-0212-04 | Nonconforming Material/Component | A defective articulation band may result in improper staple formation with possible hematosis. |
| Nov 25, 2003 | Not classified | Z-0213-04 | Nonconforming Material/Component | A defective articulation band may result in improper staple formation with possible hematosis. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K141952Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath Echelon Vascular White Reloads…Ethicon Endo-Surgery, Inc. · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K980023 (Ethicon Endo-Surgery, Inc., 1998) has gone furthest, with 88 descendants of its own.
How does its category compare?
All OCW devicesOCW Endoscopic Tissue Approximation Device: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OCW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OCW
133in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCW
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCW
326in 2025
MAUDE reports naming product code OCW, 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 | 5 | 58 | 0 | 9 |
| 2008 | 4 | 70 | 0 | 47 |
| 2009 | 3 | 30 | 0 | 30 |
| 2010 | 4 | 91 | 0 | 10 |
| 2011 | 1 | — | 0 | 16 |
| 2012 | 1 | — | 0 | 28 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 28 |
| 2015 | 0 | — | 0 | 59 |
| 2016 | 2 | — | 0 | 74 |
| 2017 | 2 | — | 0 | 420 |
| 2018 | 2 | — | 0 | 413 |
| 2019 | 1 | — | 0 | 291 |
| 2020 | 1 | — | 0 | 183 |
| 2021 | 3 | 221 | 0 | 198 |
| 2022 | 0 | — | 0 | 235 |
| 2023 | 3 | 133 | 1 | 227 |
| 2024 | 0 | — | 0 | 211 |
| 2025 | 1 | — | 0 | 326 |
| 2026 | 2 | — | 3 | — |
What is it indicated for?
The ENDOPATH® ETS Endoscopic Linear Cutter and ETS-FLEX Endoscopic Articulating Linear Cutter have application in general, urologic, gynecologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.
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/K961390 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961390: Endopath Ets Linear/Ets-Flex Articulating Linear Endoscopic Cutter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961390
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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