510(k) · Cleared
Recalled · Class II · 2023ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm
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 Jan 5, 2017 as substantially equivalent to K140560 (Ethicon Endo-Surgery, LLC, 2014) and 1 other predicate after a 27-day review. Its family tree reaches back 6 generations to 2005. 3 of the 19 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it. It has been recalled once.
- Decided
- Jan 5, 2017
- Review
- 27 days
- Class
- Class II
- Product code
- GDW
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K051002 (2005). 10 ancestors in all. 8 later devices descend from it, 2 citing it directly. 3 of the 19 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK051002 Endopath Endocutter 60 Endoscopic Linear CutterEthicon Endo-Surgery, Inc. · 2005 · Recalled
- 5 generations backK081146 Echelon Endoscopic Linear Cutters (Articulating and Straight)Ethicon Endo-Surgery, LLC · 2008 · Recalled (Class I)
- 4 generations backK112056 Echelon 60 Endoscopic Linear Cutter Reload, Black Model ECR60T…Ethicon Endo-Surgery, LLC · 2011 · Recalled
- 3 generations backK121600 Echelon 60 Endoscpic Linear Cutter Reload, WhiteEthicon Endo-Surgery, LLC · 2012
- 2 generations backK140560 Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter…Ethicon Endo-Surgery, LLC · 2014 · Recalled (Class I)
- 1 generation backK160521 ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear…Ethicon Endo-Surgery, LLC · 2016 · Recalled (Class I)
- This deviceK163454 ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear…Ethicon Endo-Surgery, LLC · 2017
- Descendant · cites it directly · 5 of its ownK213633 ECHELON 3000 45mm Stapler, ECHELON 3000 60mm StaplerEthicon Endo-Surgery, LLC · 2022
- Descendant · 2 generations on · 3 of its ownK241629 ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm…Ethicon Endo-Surgery, LLC · 2024
- Descendant · 3 generations on · 1 of its ownK250835 ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm…Ethicon Endo-Surgery, LLC · 2025
- Descendant · cites it directly · 1 of its ownK202665 Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear…Ethicon Endo-Surgery, LLC · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK254291 easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™…Ezisurg Medical Co., Ltd. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 8 · See all- K213633ECHELON 3000 45mm Stapler, ECHELON 3000 60mm StaplerEthicon Endo-Surgery, LLC · 2022 · cites it directly5descendants
- K241629ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S)…Ethicon Endo-Surgery, LLC · 2024 · 2 generations on3descendants
- K250835ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler…Ethicon Endo-Surgery, LLC · 2025 · 3 generations on1descendant
- K202665Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm…Ethicon Endo-Surgery, LLC · 2020 · cites it directly1descendant
- K254291easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use…Ezisurg Medical Co., Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K051002 | Endopath Endocutter 60 Endoscopic Linear Cutter | Ethicon Endo-Surgery, Inc. | 2005 | 1 |
| −5 | K081146 | Echelon Endoscopic Linear Cutters (Articulating and Straight) | Ethicon Endo-Surgery, LLC | 2008 | Class I |
| −4 | K112056 | Echelon 60 Endoscopic Linear Cutter Reload, Black Model ECR60T, Echelon 45… | Ethicon Endo-Surgery, LLC | 2011 | 1 |
| −3 | K121600 | Echelon 60 Endoscpic Linear Cutter Reload, White | Ethicon Endo-Surgery, LLC | 2012 | — |
| −2 | K140560 | Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter, 60MM… | Ethicon Endo-Surgery, LLC | 2014 | Class I |
| −1 | K160521 | ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter… | Ethicon Endo-Surgery, LLC | 2016 | Class I |
| 0 (this device) | K163454 | ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON… | Ethicon Endo-Surgery, LLC | 2017 | — |
| +1 | K213633 | ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler | Ethicon Endo-Surgery, LLC | 2022 | — |
| +2 | K241629 | ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler… | Ethicon Endo-Surgery, LLC | 2024 | — |
| +3 | K250835 | ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard… | Ethicon Endo-Surgery, LLC | 2025 | — |
| +1 | K202665 | Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon… | Ethicon Endo-Surgery, LLC | 2020 | 1 |
| +2 | K254291 | easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite… | Ezisurg Medical Co., Ltd. | 2026 | — |
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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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.
3 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 15.1 · 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? (2)
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 |
|---|---|---|---|
| * | K140560 | Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter, 60MM, Standard, Echelon…Summary page 4…8.4750) Regulatory Class: II Product Code: GDW III. PREDICATE DEVICES ECHELON FLEX™ 60mm Powered Plus Articulating Endoscopic Linear Cutters (K140560, K160521) ECHELON ENDOPATH™ Endoscopic Linear Cutter Reloads, 60mm (+ Gripping Surface Technology) (K140560) Reference… | 2014 |
| * | K160521 | ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mmSummary page 4…egulatory Class: II Product Code: GDW III. PREDICATE DEVICES ECHELON FLEX™ 60mm Powered Plus Articulating Endoscopic Linear Cutters (K140560, K160521) ECHELON ENDOPATH™ Endoscopic Linear Cutter Reloads, 60mm (+ Gripping Surface Technology) (K140560) Reference device Ec… | 2016 |
| † | K131663 | Echelon Endoscopic Linear Cutter Reload, Black | 2013 |
| † | K112056 | Echelon 60 Endoscopic Linear Cutter Reload, Black Model ECR60T, Echelon 45 Endoscopic… | 2011 |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 11, 2023 | Class II | Z-0834-2024 | Under Investigation by firm | There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical intervention. This may result in bleeding… |
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.
- K160521ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mmEthicon Endo-Surgery, LLC · 2016 · 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 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K081146Echelon Endoscopic Linear Cutters (Articulating and Straight)Ethicon Endo-Surgery, LLC · 2008 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- 6 of the 10 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K213633 (Ethicon Endo-Surgery, LLC, 2022) has gone furthest, with 5 descendants of its own.
- 6 other devices also cite its predicate K140560.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
ECHELON, ECHELON ENDOPATH™ 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K163454 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163454: ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163454
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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