510(k) · Cleared
ClearedETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T)
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 17, 2025 as substantially equivalent to K250835 (Ethicon Endo-Surgery, LLC, 2025) after a 111-day review. Its family tree reaches back 10 generations to 2005. 3 of the 16 devices in its family, counting itself, have a Class I recall.
- Decided
- Dec 17, 2025
- Review
- 111 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K051002 (2005). 15 ancestors in all. No later device cites it as a predicate yet. 3 of the 16 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK051002 Endopath Endocutter 60 Endoscopic Linear CutterEthicon Endo-Surgery, Inc. · 2005 · Recalled
- 6 generations between
- 3 generations backK213633 ECHELON 3000 45mm Stapler, ECHELON 3000 60mm StaplerEthicon Endo-Surgery, LLC · 2022
- 2 generations backK241629 ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm…Ethicon Endo-Surgery, LLC · 2024
- 1 generation backK250835 ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm…Ethicon Endo-Surgery, LLC · 2025
- This deviceK252739 ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm…Ethicon Endo-Surgery, LLC · 2025
Show all 10 generations
- Root · 10 generations backK051002 Endopath Endocutter 60 Endoscopic Linear CutterEthicon Endo-Surgery, Inc. · 2005 · Recalled
- 9 generations backK081146 Echelon Endoscopic Linear Cutters (Articulating and Straight)Ethicon Endo-Surgery, LLC · 2008 · Recalled (Class I)
- 8 generations backK112056 Echelon 60 Endoscopic Linear Cutter Reload, Black Model ECR60T…Ethicon Endo-Surgery, LLC · 2011 · Recalled
- 7 generations backK121600 Echelon 60 Endoscpic Linear Cutter Reload, WhiteEthicon Endo-Surgery, LLC · 2012
- 6 generations backK140560 Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter…Ethicon Endo-Surgery, LLC · 2014 · Recalled (Class I)
- 5 generations backK160521 ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear…Ethicon Endo-Surgery, LLC · 2016 · Recalled (Class I)
- 4 generations backK163454 ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear…Ethicon Endo-Surgery, LLC · 2017 · Recalled
- 3 generations backK213633 ECHELON 3000 45mm Stapler, ECHELON 3000 60mm StaplerEthicon Endo-Surgery, LLC · 2022
- 2 generations backK241629 ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm…Ethicon Endo-Surgery, LLC · 2024
- 1 generation backK250835 ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm…Ethicon Endo-Surgery, LLC · 2025
- This deviceK252739 ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm…Ethicon Endo-Surgery, LLC · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K051002 | Endopath Endocutter 60 Endoscopic Linear Cutter | Ethicon Endo-Surgery, Inc. | 2005 | 1 |
| −9 | K081146 | Echelon Endoscopic Linear Cutters (Articulating and Straight) | Ethicon Endo-Surgery, LLC | 2008 | Class I |
| −8 | K112056 | Echelon 60 Endoscopic Linear Cutter Reload, Black Model ECR60T, Echelon 45… | Ethicon Endo-Surgery, LLC | 2011 | 1 |
| −7 | K121600 | Echelon 60 Endoscpic Linear Cutter Reload, White | Ethicon Endo-Surgery, LLC | 2012 | — |
| −6 | K140560 | Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter, 60MM… | Ethicon Endo-Surgery, LLC | 2014 | Class I |
| −5 | K160521 | ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter… | Ethicon Endo-Surgery, LLC | 2016 | Class I |
| −4 | K163454 | ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON… | Ethicon Endo-Surgery, LLC | 2017 | 1 |
| −3 | 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 | — |
| −1 | K250835 | ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard… | Ethicon Endo-Surgery, LLC | 2025 | — |
| 0 (this device) | K252739 | ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard… | Ethicon Endo-Surgery, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2019 | 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.
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 15.0 · 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 |
|---|---|---|---|
| * | K250835 | ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler…Summary page 6…1 III. Predicate Device Predicate Device Predicate Device Name Predicate Device Product Models 510(k) Number K250835 ETHICONTM 4000 60mm Stapler EC3D60C, EC3D60S, EC3D60L K250835 ETHICONTM 3D 60mm Reloads… | 2025 |
| † | K241630 | ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler… | 2024 |
| † | K183435 | Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 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 · 3 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K160521ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mmEthicon Endo-Surgery, LLC · 2016 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K081146Echelon Endoscopic Linear Cutters (Articulating and Straight)Ethicon Endo-Surgery, LLC · 2008 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- 7 of the 15 ancestors have a recall of any class; 3 have a Class I recall.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 ETHICON™ 4000 45mm Staplers and ETHICON™ 3D 45mm Reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue reinforcement 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/K252739 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252739: ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252739
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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