510(k) · Cleared

Recalled · Class I · 2025

Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath Echelon Vascular White Reloads for Advanced

K141952510(k) TraditionalCleared Nov 24, 2014129-day reviewClass II21 CFR 878.4750Recalls 2 (1 Class I)

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ethicon Endo-Surgery, Inc. · GDW Staple, Implantable

Cleared on Nov 24, 2014 as substantially equivalent to K110385 (Ethicon Endo-Surgery, Inc., 2011) and 5 other predicates after a 129-day review. Its family tree reaches back 4 generations to 1982. 2 of the 29 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it. It has been recalled 2 times, including a Class I recall.

Decided: Nov 24, 2014
Review: 129 days
Class: Class II
Product code: GDW
Recalls: 2 (1 Class I)
Predicates: 6

Its longest line of descent runs back 4 generations to K821994 (1982). 24 ancestors in all. 4 later devices descend from it, 3 citing it directly. 2 of the 29 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 4 generations backK821994 Disposable Linear Stapler-(LSR)ETHICON, Inc. · 1982
3 generations backK980023 Endopath and Proximate Linear CuttersEthicon Endo-Surgery, Inc. · 1998
2 generations backK020779 Proximate and Endopath Linear Cutters and StaplersEthicon Endo-Surgery, Inc. · 2002 · Recalled
1 generation backK111111 Endopath Ets 35MM Endoscopic Linear Cutter and Reloads, and Ets-Flex…Ethicon Endo-Surgery, LLC · 2011 · Recalled
This deviceK141952 Echelon Flex Powered Vascular Stapler with Advanced Placement Tip…Ethicon Endo-Surgery, Inc. · 2014
Descendant · cites it directly · 2 of its ownK191070 Signia Small Diameter ReloadsCovidien · 2019 · Recalled
Descendant · 2 generations on · 1 of its ownK222641 Signia™ Small Diameter Reloads Including Regular (Round) Tip VersionCovidien · 2022 · Recalled
Descendant · cites it directly · 0 of its ownK254291 easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™…Ezisurg Medical Co., Ltd. · 2026
Descendant · cites it directly · 0 of its ownK253657 Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™…Covidien (Part of Medtronic) · 2026

Class I recalls in this family

K081146 Echelon Endoscopic Linear Cutters (Articulating…direct predicate · 2008

Most influential descendants

Showing 4 of 4 · See all

K191070Signia Small Diameter ReloadsCovidien · 2019 · cites it directly2descendants
K222641Signia™ Small Diameter Reloads Including Regular (Round) Tip VersionCovidien · 2022 · 2 generations on1descendant
K254291easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use…Ezisurg Medical Co., Ltd. · 2026 · cites it directly0descendants
K253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray…Covidien (Part of Medtronic) · 2026 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K821994	Disposable Linear Stapler-(LSR)	ETHICON, Inc.	1982	—
−3	K980023	Endopath and Proximate Linear Cutters	Ethicon Endo-Surgery, Inc.	1998	—
−2	K020779	Proximate and Endopath Linear Cutters and Staplers	Ethicon Endo-Surgery, Inc.	2002	17
−1	K111111	Endopath Ets 35MM Endoscopic Linear Cutter and Reloads, and Ets-Flex 35MM…	Ethicon Endo-Surgery, LLC	2011	3
0 (this device)	K141952	Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath…	Ethicon Endo-Surgery, Inc.	2014	—
+1	K191070	Signia Small Diameter Reloads	Covidien	2019	7
+2	K222641	Signia™ Small Diameter Reloads Including Regular (Round) Tip Version	Covidien	2022	1
+1	K254291	easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite…	Ezisurg Medical Co., Ltd.	2026	—
+1	K253657	Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo…	Covidien (Part of Medtronic)	2026	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
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	1	0
2000	1	0
2005	1	0
2007	1	0
2008	1	1
2011	2	0
2012	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0
2022	1	0
2026	2	0

FIG. 1 — Lineage of K141952, 1982–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 15.0 · 14 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (6)

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	Applicant	Decided	Recalls
*	K110385	Echelon Flex 45 / 60 Powered Articulating Endoscopic Linear Cutter Summary page 4 …h Implantable Staples Classification Name: Staple, Implantable Predicate Devices Echelon Flex Powered Articulating Endoscopic Linear Cutters, 45mm, 60mm (K110385, K081146) ENDOPATH ETS Flex Articulating Linear Cutter, 35mm (K111111, K070887, K020779) Echelon Endoscopic Linear…	Ethicon Endo-Surgery, Inc.	2011	—
*	K081146	Echelon Endoscopic Linear Cutters (Articulating and Straight) Summary page 4 …Staples Classification Name: Staple, Implantable Predicate Devices Echelon Flex Powered Articulating Endoscopic Linear Cutters, 45mm, 60mm (K110385, K081146) ENDOPATH ETS Flex Articulating Linear Cutter, 35mm (K111111, K070887, K020779) Echelon Endoscopic Linear Cutter Reload…	Ethicon Endo-Surgery, LLC	2008	Class I
*	K111111	Endopath Ets 35MM Endoscopic Linear Cutter and Reloads, and Ets-Flex 35MM Endoscopic… Summary page 4 …ate Devices Echelon Flex Powered Articulating Endoscopic Linear Cutters, 45mm, 60mm (K110385, K081146) ENDOPATH ETS Flex Articulating Linear Cutter, 35mm (K111111, K070887, K020779) Echelon Endoscopic Linear Cutter Reload, White (K121600, K081146, K070887) ENDOPATH ETS Endoscopic R…	Ethicon Endo-Surgery, LLC	2011	3
*	K070887	Endopath Linear Cutters and Staplers and ECHELON60 Endoscopic Linear Cutters and… Summary page 4 …es Echelon Flex Powered Articulating Endoscopic Linear Cutters, 45mm, 60mm (K110385, K081146) ENDOPATH ETS Flex Articulating Linear Cutter, 35mm (K111111, K070887, K020779) Echelon Endoscopic Linear Cutter Reload, White (K121600, K081146, K070887) ENDOPATH ETS Endoscopic Reload, Wh…	Ethicon Endo-Surgery, LLC	2007	4
*	K020779	Proximate and Endopath Linear Cutters and Staplers Summary page 4 …chelon Flex Powered Articulating Endoscopic Linear Cutters, 45mm, 60mm (K110385, K081146) ENDOPATH ETS Flex Articulating Linear Cutter, 35mm (K111111, K070887, K020779) Echelon Endoscopic Linear Cutter Reload, White (K121600, K081146, K070887) ENDOPATH ETS Endoscopic Reload, White (K111…	Ethicon Endo-Surgery, Inc.	2002	17
*	K121600	Echelon 60 Endoscpic Linear Cutter Reload, White Summary page 4 …mm, 60mm (K110385, K081146) ENDOPATH ETS Flex Articulating Linear Cutter, 35mm (K111111, K070887, K020779) Echelon Endoscopic Linear Cutter Reload, White (K121600, K081146, K070887) ENDOPATH ETS Endoscopic Reload, White (K111111, K 070887, K020779) Device Description The Eche…	Ethicon Endo-Surgery, LLC	2012	—

Also cleared against K110385: 2 other devices →

What descends from it? (4)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K191070	Signia Small Diameter Reloads	Covidien	2019	2
K254291	easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use…	Ezisurg Medical Co., Ltd.	2026	0
K253657	Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray…	Covidien (Part of Medtronic)	2026	0

Has anything in its family been recalled? (2 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 22, 2025	Class I	Z-1746-2025	Device Design	Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate but will not cut or staple tissue, and additional…
Feb 26, 2015	Class II	Z-1641-2015	Software in the Use Environment	During an internal inspection of the production process the firm discovered an issue which may cause the cartridge to deploy an incomplete staple line.

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 · Direct predicate · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 9.0 years on median.
7 of the 24 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K191070 (Covidien, 2019) has gone furthest, with 2 descendants of its own.
2 other devices also cite its predicate K110385.

How does its category compare?

All GDW devices

GDW 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

2007high 15 (2014) · low 2 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GDW

111in 2025

2007high 267 (2023) · low 27 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GDW

3in 2025

2007high 22 (2009) · low 0 (2008)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · GDW

11,905in 2025

2007high 16,600 (2019) · low 2,380 (2008)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 Flex™ Powered Vascular Stapler with Advanced Placement Tip and its reloads are intended for transection and resection of tissue and vasculature. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures.

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/K141952 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141952: Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath Echelon Vascular White Reloads for Advanced.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141952

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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