510(k) · Cleared
Recalled · Class I · 2019Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter, 60MM, Standard, Echelon Flex Powered Plus Articulating
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 Apr 22, 2014 as substantially equivalent to K130653 (Ethicon Endo-Surgery, LLC, 2013) and 6 other predicates after a 48-day review. Its family tree reaches back 4 generations to 2005. 6 of the 28 devices in its family, counting itself, have a Class I recall. 19 later devices descend from it. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Apr 22, 2014
- Review
- 48 days
- Class
- Class II
- Product code
- GDW
- Recalls
- 2 (2 Class I)
- Predicates
- 7
Its longest line of descent runs back 4 generations to K051002 (2005). 8 ancestors in all. 19 later devices descend from it, 7 citing it directly. 6 of the 28 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK051002 Endopath Endocutter 60 Endoscopic Linear CutterEthicon Endo-Surgery, Inc. · 2005 · Recalled
- 3 generations backK081146 Echelon Endoscopic Linear Cutters (Articulating and Straight)Ethicon Endo-Surgery, LLC · 2008 · Recalled (Class I)
- 2 generations backK112056 Echelon 60 Endoscopic Linear Cutter Reload, Black Model ECR60T…Ethicon Endo-Surgery, LLC · 2011 · Recalled
- 1 generation backK121600 Echelon 60 Endoscpic Linear Cutter Reload, WhiteEthicon Endo-Surgery, LLC · 2012
- This deviceK140560 Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter…Ethicon Endo-Surgery, LLC · 2014
- Descendant · cites it directly · 9 of its ownK160521 ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear…Ethicon Endo-Surgery, LLC · 2016 · Recalled (Class I)
- Descendant · cites it directly · 8 of its ownK163454 ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear…Ethicon Endo-Surgery, LLC · 2017 · Recalled
- Descendant · cites it directly · 6 of its ownK173721 SureForm 60 and SureForm 60 ReloadsIntuitive Surgical · 2018 · Recalled
- Descendant · cites it directly · 5 of its ownK213633 ECHELON 3000 45mm Stapler, ECHELON 3000 60mm StaplerEthicon Endo-Surgery, LLC · 2022
- Descendant · 2 generations on · 5 of its ownK183224 SureForm 45, SureForm 45 ReloadsIntuitive Surgical · 2019 · Recalled
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K081146 Echelon Endoscopic Linear Cutters (Articulating…2 generations back · 2008
- K160521 ECHELON FLEX 60 Powered Plus Compact…cites it directly · 2016
- K222839 EndoWrist Stapler 30 System, EndoWrist Stapler…2 generations on · 2023
- K241638 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm…3 generations on · 2024
Most influential descendants
Showing 5 of 19 · See all- K160521ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mmEthicon Endo-Surgery, LLC · 2016 · cites it directly9descendants
- K163454ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH…Ethicon Endo-Surgery, LLC · 2017 · cites it directly8descendants
- K173721SureForm 60 and SureForm 60 ReloadsIntuitive Surgical · 2018 · cites it directly6descendants
- K213633ECHELON 3000 45mm Stapler, ECHELON 3000 60mm StaplerEthicon Endo-Surgery, LLC · 2022 · cites it directly5descendants
- K183224SureForm 45, SureForm 45 ReloadsIntuitive Surgical · 2019 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K051002 | Endopath Endocutter 60 Endoscopic Linear Cutter | Ethicon Endo-Surgery, Inc. | 2005 | 1 |
| −3 | K081146 | Echelon Endoscopic Linear Cutters (Articulating and Straight) | Ethicon Endo-Surgery, LLC | 2008 | Class I |
| −2 | K112056 | Echelon 60 Endoscopic Linear Cutter Reload, Black Model ECR60T, Echelon 45… | Ethicon Endo-Surgery, LLC | 2011 | 1 |
| −1 | K121600 | Echelon 60 Endoscpic Linear Cutter Reload, White | Ethicon Endo-Surgery, LLC | 2012 | — |
| 0 (this device) | K140560 | Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter, 60MM… | Ethicon Endo-Surgery, LLC | 2014 | — |
| +1 | K160521 | ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter… | Ethicon Endo-Surgery, LLC | 2016 | Class I |
| +1 | K163454 | ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON… | Ethicon Endo-Surgery, LLC | 2017 | 1 |
| +1 | K173721 | SureForm 60 and SureForm 60 Reloads | Intuitive Surgical | 2018 | 3 |
| +1 | K213633 | ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler | Ethicon Endo-Surgery, LLC | 2022 | — |
| +2 | K183224 | SureForm 45, SureForm 45 Reloads | Intuitive Surgical | 2019 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 1 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 1 |
| 2022 | 1 | 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.
6 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? (7)
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 |
|---|---|---|---|
| * | K130653 | Echelon Flex 45 Powered Articulating Endoscopic Linear Cutter; Echelon Flex 60 Powered…Summary page 1…Name: Surgical Stapler with Implantable Staples Classification Name: Staple, Implantable Predicate Devices Echelon Flex Powered Articulating Endoscopic Linear Cutters (K 130653, KI 10385) Echelon Endoscopic Linear Cutter Reload, White (K121600, K070887, K051002) Echelon Endoscopic Linear Cutter Reload, Bl… | 2013 |
| * | K110385 | Echelon Flex 45 / 60 Powered Articulating Endoscopic Linear Cutter | 2011 |
| * | K121600 | Echelon 60 Endoscpic Linear Cutter Reload, WhiteSummary page 1…: Staple, Implantable Predicate Devices Echelon Flex Powered Articulating Endoscopic Linear Cutters (K 130653, KI 10385) Echelon Endoscopic Linear Cutter Reload, White (K121600, K070887, K051002) Echelon Endoscopic Linear Cutter Reload, Blue (K070887, K05 1002) Echelon Endoscopic Lin~ear Cutter Reload, Go… | 2012 |
| * | K070887 | Endopath Linear Cutters and Staplers and ECHELON60 Endoscopic Linear Cutters and…Summary page 1…Implantable Predicate Devices Echelon Flex Powered Articulating Endoscopic Linear Cutters (K 130653, KI 10385) Echelon Endoscopic Linear Cutter Reload, White (K121600, K070887, K051002) Echelon Endoscopic Linear Cutter Reload, Blue (K070887, K05 1002) Echelon Endoscopic Lin~ear Cutter Reload, Gold (K0708… | 2007 |
| * | K051002 | Endopath Endocutter 60 Endoscopic Linear CutterSummary page 1…ble Predicate Devices Echelon Flex Powered Articulating Endoscopic Linear Cutters (K 130653, KI 10385) Echelon Endoscopic Linear Cutter Reload, White (K121600, K070887, K051002) Echelon Endoscopic Linear Cutter Reload, Blue (K070887, K05 1002) Echelon Endoscopic Lin~ear Cutter Reload, Gold (K070887, K05 1… | 2005 |
| * | K131663 | Echelon Endoscopic Linear Cutter Reload, BlackSummary page 1…opic Lin~ear Cutter Reload, Gold (K070887, K05 1002) Echelon Endoscopic Linear Cutter Reload, Green (K070887, K05 1002) Echelon Endoscopic Linear Cutter Reload, Black (Kl131663 KI 12056) Device Description The Echelon Flex Powered Plus Articulating Endoscopic Linear Cutters are sterile, single patient us… | 2013 |
| * | K112056 | Echelon 60 Endoscopic Linear Cutter Reload, Black Model ECR60T, Echelon 45 Endoscopic…Summary page 2…e of the devices or alter fundamental scientific technology of the devices. Many of the new features added to the reloads were introduced in prior reload submissions (KI 112056, K121600). MR compatibility data has been derived from the testing performed for the currently marketed Echelon Black reload. The… | 2011 |
What descends from it? (19)
See all 197 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160521 | ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm Class I | 2016 | 9 |
| K163454 | ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH… | 2017 | 8 |
| K173721 | SureForm 60 and SureForm 60 Reloads | 2018 | 6 |
| K213633 | ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler | 2022 | 5 |
| K183435 | Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black | 2019 | 3 |
| K202665 | Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm… | 2020 | 1 |
| K210278 | Titan SGS | 2021 | 0 |
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 3, 2019 | Class I | Z-0202-2020 | Nonconforming Material/Component | The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a… |
| Oct 3, 2019 | Class I | Z-0203-2020 | Nonconforming Material/Component | The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a… |
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 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K160521ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mmEthicon Endo-Surgery, LLC · 2016 · Cites it directly · ◆ 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 · 2 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 · 3 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 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- 4 of the 8 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K160521 (Ethicon Endo-Surgery, LLC, 2016) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K130653.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 ENDOPATH ECHELON" and ECHELON FLEX" families of endoscopic linear cutters and reloads 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/K140560 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140560: Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter, 60MM, Standard, Echelon Flex Powered Plus Articulating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140560
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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