510(k) · Cleared
Recalled · Class II · 2013Echelon 60 Endoscopic Linear Cutter Reload, Black Model ECR60T, Echelon 45 Endoscopic Linear Cutter Reload, Black Model
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 Dec 19, 2011 as substantially equivalent to K081146 (Ethicon Endo-Surgery, LLC, 2008) and 2 other predicates after a 153-day review. Its family tree reaches back 2 generations to 2005. 7 of the 29 devices in its family, counting itself, have a Class I recall. 25 later devices descend from it. It has been recalled once.
- Decided
- Dec 19, 2011
- Review
- 153 days
- Class
- Class II
- Product code
- GDW
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K051002 (2005). 3 ancestors in all. 25 later devices descend from it, 3 citing it directly. 7 of the 29 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK051002 Endopath Endocutter 60 Endoscopic Linear CutterEthicon Endo-Surgery, Inc. · 2005 · Recalled
- 1 generation backK081146 Echelon Endoscopic Linear Cutters (Articulating and Straight)Ethicon Endo-Surgery, LLC · 2008 · Recalled (Class I)
- This deviceK112056 Echelon 60 Endoscopic Linear Cutter Reload, Black Model ECR60T…Ethicon Endo-Surgery, LLC · 2011
- Descendant · cites it directly · 23 of its ownK121600 Echelon 60 Endoscpic Linear Cutter Reload, WhiteEthicon Endo-Surgery, LLC · 2012
- Descendant · cites it directly · 20 of its ownK131663 Echelon Endoscopic Linear Cutter Reload, BlackEthicon Endo-Surgery, LLC · 2013
- Descendant · cites it directly · 19 of its ownK140560 Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter…Ethicon Endo-Surgery, LLC · 2014 · Recalled (Class I)
- Descendant · 2 generations on · 9 of its ownK160521 ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear…Ethicon Endo-Surgery, LLC · 2016 · Recalled (Class I)
- Descendant · 2 generations on · 8 of its ownK163454 ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear…Ethicon Endo-Surgery, LLC · 2017 · Recalled
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 25 · See all- K121600Echelon 60 Endoscpic Linear Cutter Reload, WhiteEthicon Endo-Surgery, LLC · 2012 · cites it directly23descendants
- K131663Echelon Endoscopic Linear Cutter Reload, BlackEthicon Endo-Surgery, LLC · 2013 · cites it directly20descendants
- K140560Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter, 60MM, Standard, Echelon…Ethicon Endo-Surgery, LLC · 2014 · cites it directly19descendants
- K160521ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mmEthicon Endo-Surgery, LLC · 2016 · 2 generations on9descendants
- K163454ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH…Ethicon Endo-Surgery, LLC · 2017 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K051002 | Endopath Endocutter 60 Endoscopic Linear Cutter | Ethicon Endo-Surgery, Inc. | 2005 | 1 |
| −1 | K081146 | Echelon Endoscopic Linear Cutters (Articulating and Straight) | Ethicon Endo-Surgery, LLC | 2008 | Class I |
| 0 (this device) | K112056 | Echelon 60 Endoscopic Linear Cutter Reload, Black Model ECR60T, Echelon 45… | Ethicon Endo-Surgery, LLC | 2011 | — |
| +1 | K121600 | Echelon 60 Endoscpic Linear Cutter Reload, White | Ethicon Endo-Surgery, LLC | 2012 | — |
| +1 | K131663 | Echelon Endoscopic Linear Cutter Reload, Black | Ethicon Endo-Surgery, LLC | 2013 | — |
| +1 | K140560 | Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter, 60MM… | Ethicon Endo-Surgery, LLC | 2014 | Class I |
| +2 | K160521 | ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter… | Ethicon Endo-Surgery, LLC | 2016 | Class I |
| +2 | K163454 | ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON… | Ethicon Endo-Surgery, LLC | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 2 |
| 2016 | 1 | 1 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 1 |
| 2022 | 2 | 0 |
| 2023 | 1 | 1 |
| 2024 | 3 | 1 |
| 2025 | 3 | 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.
7 devices in this family have 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 |
|---|---|---|---|
| * | K081146 | Echelon Endoscopic Linear Cutters (Articulating and Straight)Summary page 1…essory Classification Name: Staple, lImplantable Predicate Device Echelon Endoscopic Linear Cutters Reload, Green (cleared under K(081146, K070887, K(051002) Device Description The Echelon Endoscopic Linear Cutter Reload, Black is a thick tissue reload for use with… | 2008 |
| * | K070887 | Endopath Linear Cutters and Staplers and ECHELON60 Endoscopic Linear Cutters and…Summary page 1…Classification Name: Staple, lImplantable Predicate Device Echelon Endoscopic Linear Cutters Reload, Green (cleared under K(081146, K070887, K(051002) Device Description The Echelon Endoscopic Linear Cutter Reload, Black is a thick tissue reload for use with the Eche… | 2007 |
| * | K051002 | Endopath Endocutter 60 Endoscopic Linear CutterSummary page 1…Classification Name: Staple, lImplantable Predicate Device Echelon Endoscopic Linear Cutters Reload, Green (cleared under K(081146, K070887, K(051002) Device Description The Echelon Endoscopic Linear Cutter Reload, Black is a thick tissue reload for use with the Echelon Endosc… | 2005 |
What descends from it? (25)
See all 253 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (7 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 13, 2013 | Class II | Z-1530-2013 | Device Design | Ethicon Endo-Surgery is initiating a voluntary worldwide recall for ECHELON 60mm Black Reload (ECR60T) due to the potential for incomplete staple line formation from reload damage during the firing sequence. |
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.
- K081146Echelon Endoscopic Linear Cutters (Articulating and Straight)Ethicon Endo-Surgery, LLC · 2008 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K140560Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter, 60MM, Standard, Echelon Flex Powered Plus…Ethicon Endo-Surgery, LLC · 2014 · Cites it directly · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
- 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
- K160521ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mmEthicon Endo-Surgery, LLC · 2016 · 2 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K222839EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm…Intuitive Surgical, Inc. · 2023 · 3 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K2416388mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 ReloadsIntuitive Surgical, Inc. · 2024 · 4 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K2119978 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 ReloadsIntuitive Surgical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
Nearest 5 of 7; all are on the web page.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- 3 of the 3 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K121600 (Ethicon Endo-Surgery, LLC, 2012) has gone furthest, with 23 descendants of its own.
- 5 other devices also cite its predicate K081146.
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?
The ECHELON families of endoscopic 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 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/K112056 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112056: Echelon 60 Endoscopic Linear Cutter Reload, Black Model ECR60T, Echelon 45 Endoscopic Linear Cutter Reload, Black Model.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112056
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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