510(k) · Cleared
Recalled · 2011Endopath Endocutter 60 Endoscopic Linear Cutter, Models EC60, SC60 and LONG60 and Endopath & Proximate Linear Cutters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Surgery, Inc. · GDW Staple, Implantable
Cleared on Jul 3, 2006 after a 68-day review. The FDA summary names its predicate without a number. 63 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 3, 2006
- Review
- 68 days
- Class
- Class II
- Product code
- GDW
- Recalls
- 2
- Predicates
- 0
63 later devices descend from it, 7 citing it directly.
- This deviceK061156 Endopath Endocutter 60 Endoscopic Linear Cutter, Models EC60, SC60…Ethicon Endo-Surgery, Inc. · 2006
- Descendant · cites it directly · 61 of its ownK062869 Contour Curved Cutter Stapler and Reloads, Models CS40B, CS40G…Ethicon Endo-Surgery, LLC · 2007
- Descendant · 2 generations on · 60 of its ownK091322 Contour Curved Cutter Stapler and Reloads, Models: CS40B, CS40G…Ethicon Endo-Surgery, Inc. · 2009
- Descendant · 3 generations on · 45 of its ownK102291 Covidien Endo Gia Radial Reload with Tri-Staple TechnologyCovidien · 2010
- Descendant · 4 generations on · 44 of its ownK111825 Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · Recalled
- Descendant · 3 generations on · 14 of its ownK131511 Disposable Circular Stapler, Disposable Curved Cutter Stapler…Changzhou Sinolinks Medical Innovation Co., Ltd. · 2013
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 63 · See all- K062869Contour Curved Cutter Stapler and Reloads, Models CS40B, CS40G, CR40B and CR40GEthicon Endo-Surgery, LLC · 2007 · cites it directly61descendants
- K091322Contour Curved Cutter Stapler and Reloads, Models: CS40B, CS40G, CR40B, CR40GEthicon Endo-Surgery, Inc. · 2009 · 2 generations on60descendants
- K102291Covidien Endo Gia Radial Reload with Tri-Staple TechnologyCovidien · 2010 · 3 generations on45descendants
- K111825Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM)…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · 4 generations on44descendants
- K131511Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable Linear…Changzhou Sinolinks Medical Innovation Co., Ltd. · 2013 · 3 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061156 | Endopath Endocutter 60 Endoscopic Linear Cutter, Models EC60, SC60 and LONG60… | Ethicon Endo-Surgery, Inc. | 2006 | — |
| +1 | K062869 | Contour Curved Cutter Stapler and Reloads, Models CS40B, CS40G, CR40B and CR40G | Ethicon Endo-Surgery, LLC | 2007 | — |
| +2 | K091322 | Contour Curved Cutter Stapler and Reloads, Models: CS40B, CS40G, CR40B, CR40G | Ethicon Endo-Surgery, Inc. | 2009 | — |
| +3 | K102291 | Covidien Endo Gia Radial Reload with Tri-Staple Technology | Covidien | 2010 | — |
| +4 | K111825 | Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA… | Covidien, Formerly US Surgical A Divison of Tyco H | 2011 | 73 |
| +3 | K131511 | Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable… | Changzhou Sinolinks Medical Innovation Co., Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 7 | 0 |
| 2015 | 4 | 0 |
| 2016 | 6 | 0 |
| 2017 | 7 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 6 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 GDW? 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? (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 |
|---|---|---|---|
| * | — | ENDOPATH Linear Cutters and Staplers Named without a submission number |
What descends from it? (63)
See all 637 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062869 | Contour Curved Cutter Stapler and Reloads, Models CS40B, CS40G, CR40B and CR40G | 2007 | 61 |
| K172960 | easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal… | 2017 | 1 |
| K162707 | Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient… | 2017 | 1 |
| K181620 | Endoscopic Linear Cutting Staplers and Loading Units for Single Use | 2018 | 0 |
| K162947 | Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting… | 2017 | 0 |
| K162710 | Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient… | 2017 | 0 |
| K150026 | Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife… | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 29, 2011 | Not classified | Z-3187-2011 | Packaging | Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENDOPATH ETS Compact Flex 45mm articulating linear cutters because the possibility exists that damage to the blister pack may have compromised the… |
| Mar 27, 2009 | Not classified | Z-1069-2011 | Other | The firm initiated this second subsequent recall because the affected devices can remain closed and clamped on tissue during surgical procedures due to the fact that the mechanism which connects the articulation joint to the device shaft… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K062869 (Ethicon Endo-Surgery, LLC, 2007) has gone furthest, with 61 descendants of its own.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The ENDOPATH Endocutter 60 Endoscopic Linear Cutter is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. It can be used with staple line or tissue buttressing materials. The ENDOPATH ETS45 Endoscopic Linear Cutters, the ETS-Flex45 Endoscopic Articulating Linear Cutters, and the ETS…
Read the full statement (257 words)
The ENDOPATH Endocutter 60 Endoscopic Linear Cutter is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. It can be used with staple line or tissue buttressing materials.
The ENDOPATH ETS45 Endoscopic Linear Cutters, the ETS-Flex45 Endoscopic Articulating Linear Cutters, and the ETS Compact-Flex45 Articulating Linear Cutters are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials.
The ENDOPATH ETS-Flex45 No-Knife Articulating Linear Staplers and the ETS Compact-Flex45 No-Knife Articulating Linear Staplers are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials.
The ENDOPATH EZ45 Endoscopic Linear Cutter has application in multiple open and other minimally invasive surgical procedures for transection, resection, and/or creation of anastomoses and can be used with staple line or tissue buttressing materials.
The ENDOPATH EZ45 No-Knife Endoscopic Linear Stapler has application in multiple open or other minimally invasive surgical procedures for transection and resection, and can be used with staple line or tissue buttressing materials.
The ENDOPATH EZ45 Thoracic Endoscopic Linear Cutter has application in thoracic surgery or other minimally invasive surgical procedures for transection, resection, and/or creation of anastomoses and can be used with staple line buttressing materials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061156 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061156: Endopath Endocutter 60 Endoscopic Linear Cutter, Models EC60, SC60 and LONG60 and Endopath & Proximate Linear Cutters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061156
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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