510(k) · Cleared
ClearedeasyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use Cartridges
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ezisurg Medical Co., Ltd. · GDW Staple, Implantable
Cleared on Sep 25, 2026 as substantially equivalent to K202665 (Ethicon Endo-Surgery, LLC, 2020) and 1 other predicate after a 268-day review. Its family tree reaches back 8 generations to 2005. 4 of the 32 devices in its family, counting itself, have a Class I recall.
- Decided
- Sep 25, 2026
- Review
- 268 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K051002 (2005). 31 ancestors in all, the oldest K821994 (1982). No later device cites it as a predicate yet. 4 of the 32 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK051002 Endopath Endocutter 60 Endoscopic Linear CutterEthicon Endo-Surgery, Inc. · 2005 · Recalled
- 7 generations backK081146 Echelon Endoscopic Linear Cutters (Articulating and Straight)Ethicon Endo-Surgery, LLC · 2008 · Recalled (Class I)
- 6 generations backK112056 Echelon 60 Endoscopic Linear Cutter Reload, Black Model ECR60T…Ethicon Endo-Surgery, LLC · 2011 · Recalled
- 5 generations backK121600 Echelon 60 Endoscpic Linear Cutter Reload, WhiteEthicon Endo-Surgery, LLC · 2012
- 4 generations backK140560 Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter…Ethicon Endo-Surgery, LLC · 2014 · Recalled (Class I)
- 3 generations backK160521 ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear…Ethicon Endo-Surgery, LLC · 2016 · Recalled (Class I)
- 2 generations backK163454 ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear…Ethicon Endo-Surgery, LLC · 2017 · Recalled
- 1 generation backK202665 Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear…Ethicon Endo-Surgery, LLC · 2020 · Recalled
- This deviceK254291 easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™…Ezisurg Medical Co., Ltd. · 2026
Class I recalls in this family
- K141952 Echelon Flex Powered Vascular Stapler with…direct predicate · 2014
- K160521 ECHELON FLEX 60 Powered Plus Compact…2 generations back · 2016
- K140560 Echelon Flex Powered Plus Articulating…2 generations back · 2014
- K081146 Echelon Endoscopic Linear Cutters (Articulating…2 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K051002 | Endopath Endocutter 60 Endoscopic Linear Cutter | Ethicon Endo-Surgery, Inc. | 2005 | 1 |
| −7 | K081146 | Echelon Endoscopic Linear Cutters (Articulating and Straight) | Ethicon Endo-Surgery, LLC | 2008 | Class I |
| −6 | K112056 | Echelon 60 Endoscopic Linear Cutter Reload, Black Model ECR60T, Echelon 45… | Ethicon Endo-Surgery, LLC | 2011 | 1 |
| −5 | K121600 | Echelon 60 Endoscpic Linear Cutter Reload, White | Ethicon Endo-Surgery, LLC | 2012 | — |
| −4 | K140560 | Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter, 60MM… | Ethicon Endo-Surgery, LLC | 2014 | Class I |
| −3 | 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 |
| −1 | K202665 | Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon… | Ethicon Endo-Surgery, LLC | 2020 | 1 |
| 0 (this device) | 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 |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 1 |
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.
4 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 |
|---|---|---|---|
| * | K202665 | Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm…Summary page 6…s) Device name: ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX families of endoscopic linear cutters and reloads 510(k) number: K202665 Manufacturer: Ethicon Endo-Surgery, LLC Device Name: Echelon FlexTM Powered Vascular Stapler with Advanced… | 2020 |
| * | K141952 | Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath Echelon…Summary page 6…65 Manufacturer: Ethicon Endo-Surgery, LLC Device Name: Echelon FlexTM Powered Vascular Stapler with Advanced Placement Tip 510(k) Number: K141952 Manufacturer: Ethicon Endo-Surgery, LLC 6. Device Description The easyEndoTM E-Lite (previously named: easyEndo™ P… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 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.
- K141952Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath Echelon Vascular White Reloads…Ethicon Endo-Surgery, Inc. · 2014 · Direct predicate · ◆ in the 2014 ancestors bar of FIG. 11 Class I recall
- K160521ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mmEthicon Endo-Surgery, LLC · 2016 · 2 generations back · ◆ 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 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- 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
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 12 of the 31 ancestors have a recall of any class; 4 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. 2026, 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?
easyEndoTM E-Lite Single Use Powered Endoscopic Staplers are intended for transection, resection, and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general and thoracic surgical procedures. easyEndoTM E-Lite Single Use Powered Endoscopic Staplers with Curved Tip are intended for transection, resection, and/or creation of anastomoses. The instruments have applications in multiple open or minimally…
Read the full statement (94 words)
easyEndoTM E-Lite Single Use Powered Endoscopic Staplers are intended for transection, resection, and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general and thoracic surgical procedures.
easyEndoTM E-Lite Single Use Powered Endoscopic Staplers with Curved Tip are intended for transection, resection, and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general and thoracic surgical procedures.
easyEndoTM E-Lite Single Use Cartridges are intended for transection, resection, and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general and thoracic surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254291 · printed Nov 5, 2026
Cite this page
510(k) Report. “K254291: easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use Cartridges.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K254291
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026