510(k) · Cleared
Recalled · Class II · 2017Endopath Ets 35MM Endoscopic Linear Cutter and Reloads, and Ets-Flex 35MM Endoscopic Articulating Linear Cutter and Relo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Surgery, LLC · GDW Staple, Implantable
Cleared on Jun 8, 2011 as substantially equivalent to K961390 (Ethicon Endo-Surgery, Inc., 1996) and 2 other predicates after a 49-day review. Its family tree reaches back 3 generations to 1982. 1 of the 24 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it. It has been recalled 3 times.
- Decided
- Jun 8, 2011
- Review
- 49 days
- Class
- Class II
- Product code
- GDW
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 3 generations to K821994 (1982). 18 ancestors in all. 5 later devices descend from it, 1 citing it directly. 1 of the 24 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK821994 Disposable Linear Stapler-(LSR)ETHICON, Inc. · 1982
- 2 generations backK980023 Endopath and Proximate Linear CuttersEthicon Endo-Surgery, Inc. · 1998
- 1 generation backK020779 Proximate and Endopath Linear Cutters and StaplersEthicon Endo-Surgery, Inc. · 2002 · Recalled
- This deviceK111111 Endopath Ets 35MM Endoscopic Linear Cutter and Reloads, and Ets-Flex…Ethicon Endo-Surgery, LLC · 2011
- Descendant · cites it directly · 4 of its ownK141952 Echelon Flex Powered Vascular Stapler with Advanced Placement Tip…Ethicon Endo-Surgery, Inc. · 2014 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK191070 Signia Small Diameter ReloadsCovidien · 2019 · Recalled
- Descendant · 3 generations on · 1 of its ownK222641 Signia™ Small Diameter Reloads Including Regular (Round) Tip VersionCovidien · 2022 · Recalled
- Descendant · 2 generations on · 0 of its ownK254291 easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™…Ezisurg Medical Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK253657 Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™…Covidien (Part of Medtronic) · 2026
Class I recalls in this family
- K141952 Echelon Flex Powered Vascular Stapler with…cites it directly · 2014
Most influential descendants
Showing 5 of 5 · See all- K141952Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath Echelon…Ethicon Endo-Surgery, Inc. · 2014 · cites it directly4descendants
- K191070Signia Small Diameter ReloadsCovidien · 2019 · 2 generations on2descendants
- K222641Signia™ Small Diameter Reloads Including Regular (Round) Tip VersionCovidien · 2022 · 3 generations on1descendant
- K254291easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use…Ezisurg Medical Co., Ltd. · 2026 · 2 generations on0descendants
- K253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray…Covidien (Part of Medtronic) · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K821994 | Disposable Linear Stapler-(LSR) | ETHICON, Inc. | 1982 | — |
| −2 | 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 |
| 0 (this device) | K111111 | Endopath Ets 35MM Endoscopic Linear Cutter and Reloads, and Ets-Flex 35MM… | Ethicon Endo-Surgery, LLC | 2011 | — |
| +1 | K141952 | Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath… | Ethicon Endo-Surgery, Inc. | 2014 | Class I |
| +2 | K191070 | Signia Small Diameter Reloads | Covidien | 2019 | 7 |
| +3 | K222641 | Signia™ Small Diameter Reloads Including Regular (Round) Tip Version | Covidien | 2022 | 1 |
| +2 | K254291 | easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite… | Ezisurg Medical Co., Ltd. | 2026 | — |
| +2 | K253657 | Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo… | Covidien (Part of Medtronic) | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 1 |
| 2019 | 1 | 0 |
| 2022 | 1 | 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.
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 GDW device
- #1 K253657 Tri-staple 2.0™ Reloads; Endo GIA™ Reloads…score 15.0 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K961390 | Endopath Ets Linear/Ets-Flex Articulating Linear Endoscopic CutterSummary page 1…S- Rlex 35mm Endoscopic Articulating Linear Cutter and Reloads Common Name: Staple, Inmplantable Regulatory Class: 21 CER 878.4750 Product Code: GDW Predicate Device(s): K961390 35mm ENDOPATH® ETS Endoscopic Linear Cutter and ETS- Flex Endoscopic Articulating Linear Cutter, K020779 35mm ENDOPATH®D ETS Endo… | 1996 |
| * | K020779 | Proximate and Endopath Linear Cutters and StaplersSummary page 1…ry Class: 21 CER 878.4750 Product Code: GDW Predicate Device(s): K961390 35mm ENDOPATH® ETS Endoscopic Linear Cutter and ETS- Flex Endoscopic Articulating Linear Cutter, K020779 35mm ENDOPATH®D ETS Endoscopic Linear Cutter and ETS-Flex Endoscopic Articulating Linear Cutter, K070887 ENDOPATH® and Echelon Li… | 2002 |
| * | K070887 | Endopath Linear Cutters and Staplers and ECHELON60 Endoscopic Linear Cutters and…Summary page 1…near Cutter and ETS- Flex Endoscopic Articulating Linear Cutter, K020779 35mm ENDOPATH®D ETS Endoscopic Linear Cutter and ETS-Flex Endoscopic Articulating Linear Cutter, K070887 ENDOPATH® and Echelon Linear Cutters. Staplers and Reloads Device Description: The ENDOPATH ETS 35mm Endoscopic Linear Cutter a… | 2007 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141952 | Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath Echelon… Class I | 2014 | 4 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 31, 2017 | Class II | Z-2174-2017 | Process control | There is a risk that the pinion gear in the device could fail under extreme use cases. |
| Jul 15, 2016 | Class II | Z-0295-2017 | Device Design | Quality control identified a component issue where the pinion gear in the device could fail under extreme use cases. If this condition occurs, staples will be formed past the cut line and the device can be opened and removed from the… |
| Jul 15, 2016 | Class II | Z-0296-2017 | Device Design | Quality control identified a component issue where the pinion gear in the device could fail under extreme use cases. If this condition occurs, staples will be formed past the cut line and the device can be opened and removed from the… |
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 · Cites it directly · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 9.0 years on median.
- 3 of the 18 ancestors have a recall of any class.
- Of its descendants, K141952 (Ethicon Endo-Surgery, Inc., 2014) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K961390.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · GDW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GDW
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GDW
3in 2025
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · GDW
11,905in 2025
MAUDE reports naming product code GDW, 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 | 8 | 56 | 9 | 2,401 |
| 2008 | 7 | 57 | 0 | 2,380 |
| 2009 | 13 | 27 | 22 | 4,014 |
| 2010 | 10 | 39 | 2 | 3,768 |
| 2011 | 11 | 49 | 9 | 3,826 |
| 2012 | 9 | 45 | 11 (1) | 3,717 |
| 2013 | 13 | 49 | 1 | 3,777 |
| 2014 | 15 | 63 | 0 | 4,784 |
| 2015 | 8 | 111 | 6 | 4,899 |
| 2016 | 11 | 96 | 2 | 5,106 |
| 2017 | 13 | 103 | 3 | 11,643 |
| 2018 | 7 | 90 | 3 | 14,914 |
| 2019 | 12 | 205 | 4 (4) | 16,600 |
| 2020 | 10 | 88 | 11 | 12,332 |
| 2021 | 9 | 233 | 0 | 13,015 |
| 2022 | 7 | 89 | 0 | 13,605 |
| 2023 | 4 | 267 | 1 | 14,623 |
| 2024 | 2 | — | 0 | 13,280 |
| 2025 | 3 | 111 | 3 | 11,905 |
| 2026 | 3 | 141 | 0 | — |
What is it indicated for?
ENDOPATH ETS 35mm Endoscopic Linear Cutter and Reloads, and ETS-Flex 35mm Endoscopic Articulating Linear Cutter and Reloads have application in general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111111 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111111: Endopath Ets 35MM Endoscopic Linear Cutter and Reloads, and Ets-Flex 35MM Endoscopic Articulating Linear Cutter and Relo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111111
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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