510(k) · Cleared
ClearedEchelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black
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 Feb 6, 2019 as substantially equivalent to K140560 (Ethicon Endo-Surgery, LLC, 2014) after a 57-day review. Its family tree reaches back 5 generations to 2005. 2 of the 13 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it.
- Decided
- Feb 6, 2019
- Review
- 57 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K051002 (2005). 9 ancestors in all. 3 later devices descend from it, 2 citing it directly. 2 of the 13 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK051002 Endopath Endocutter 60 Endoscopic Linear CutterEthicon Endo-Surgery, Inc. · 2005 · Recalled
- 4 generations backK081146 Echelon Endoscopic Linear Cutters (Articulating and Straight)Ethicon Endo-Surgery, LLC · 2008 · Recalled (Class I)
- 3 generations backK112056 Echelon 60 Endoscopic Linear Cutter Reload, Black Model ECR60T…Ethicon Endo-Surgery, LLC · 2011 · Recalled
- 2 generations backK121600 Echelon 60 Endoscpic Linear Cutter Reload, WhiteEthicon Endo-Surgery, LLC · 2012
- 1 generation backK140560 Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter…Ethicon Endo-Surgery, LLC · 2014 · Recalled (Class I)
- This deviceK183435 Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green…Ethicon Endo-Surgery, LLC · 2019
- Descendant · cites it directly · 1 of its ownK250835 ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm…Ethicon Endo-Surgery, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK252739 ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm…Ethicon Endo-Surgery, LLC · 2025
- Descendant · cites it directly · 0 of its ownK241630 ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm…Ethicon Endo-Surgery, LLC · 2024
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · See all- K250835ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler…Ethicon Endo-Surgery, LLC · 2025 · cites it directly1descendant
- K252739ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler…Ethicon Endo-Surgery, LLC · 2025 · 2 generations on0descendants
- K241630ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler…Ethicon Endo-Surgery, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K051002 | Endopath Endocutter 60 Endoscopic Linear Cutter | Ethicon Endo-Surgery, Inc. | 2005 | 1 |
| −4 | K081146 | Echelon Endoscopic Linear Cutters (Articulating and Straight) | Ethicon Endo-Surgery, LLC | 2008 | Class I |
| −3 | K112056 | Echelon 60 Endoscopic Linear Cutter Reload, Black Model ECR60T, Echelon 45… | Ethicon Endo-Surgery, LLC | 2011 | 1 |
| −2 | K121600 | Echelon 60 Endoscpic Linear Cutter Reload, White | Ethicon Endo-Surgery, LLC | 2012 | — |
| −1 | K140560 | Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter, 60MM… | Ethicon Endo-Surgery, LLC | 2014 | Class I |
| 0 (this device) | K183435 | Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black | Ethicon Endo-Surgery, LLC | 2019 | — |
| +1 | K250835 | ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard… | Ethicon Endo-Surgery, LLC | 2025 | — |
| +2 | K252739 | ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard… | Ethicon Endo-Surgery, LLC | 2025 | — |
| +1 | K241630 | ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard… | Ethicon Endo-Surgery, LLC | 2024 | — |
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 |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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.
2 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? (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 |
|---|---|---|---|
| * | K140560 | Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter, 60MM, Standard, Echelon…Summary page 4…inear Cutter Reload, Green (+ Gripping Surface Technology) Echelon Endoscopic Linear Cutter Reload, Black (+ Gripping Surface Technology) Predicate Devices Trade Name (K140560) Echelon Endoscopic Linear Cutter Reload, White (+ Gripping Surface Technology) Echelon Endoscopic Linear Cutter Reload, Blue (+… | 2014 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
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.
- 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 14 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- 5 of the 9 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K250835 (Ethicon Endo-Surgery, LLC, 2025) has gone furthest, with 1 descendant 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. 2019, 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, 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 as stated in the FDA summary.
https://510kreport.com/device/K183435 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183435: Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183435
Report an extraction error
Are you the manufacturer?
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