510(k) · Cleared

Recalled · Class I · 2019

Echelon Endoscopic Linear Cutters (Articulating and Straight)

K081146510(k) TraditionalCleared Jun 26, 200865-day reviewClass II21 CFR 878.4750Recalls 1 (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, LLC · GDW Staple, Implantable

Cleared on Jun 26, 2008 as substantially equivalent to K051002 (Ethicon Endo-Surgery, Inc., 2005) and 1 other predicate after a 65-day review. Its family tree reaches back 1 generation to 2005. 7 of the 53 devices in its family, counting itself, have a Class I recall. 50 later devices descend from it. It has been recalled once, including a Class I recall.

Decided: Jun 26, 2008
Review: 65 days
Class: Class II
Product code: GDW
Recalls: 1 (1 Class I)
Predicates: 2

Its longest line of descent runs back 1 generation to K051002 (2005). 2 ancestors in all. 50 later devices descend from it, 6 citing it directly. 7 of the 53 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK051002 Endopath Endocutter 60 Endoscopic Linear CutterEthicon Endo-Surgery, Inc. · 2005 · Recalled
This deviceK081146 Echelon Endoscopic Linear Cutters (Articulating and Straight)Ethicon Endo-Surgery, LLC · 2008
Descendant · cites it directly · 27 of its ownK110385 Echelon Flex 45 / 60 Powered Articulating Endoscopic Linear CutterEthicon Endo-Surgery, Inc. · 2011
Descendant · cites it directly · 25 of its ownK112056 Echelon 60 Endoscopic Linear Cutter Reload, Black Model ECR60T…Ethicon Endo-Surgery, LLC · 2011 · Recalled
Descendant · 2 generations on · 23 of its ownK130653 Echelon Flex 45 Powered Articulating Endoscopic Linear Cutter…Ethicon Endo-Surgery, LLC · 2013
Descendant · cites it directly · 23 of its ownK121600 Echelon 60 Endoscpic Linear Cutter Reload, WhiteEthicon Endo-Surgery, LLC · 2012
Descendant · 2 generations on · 20 of its ownK131663 Echelon Endoscopic Linear Cutter Reload, BlackEthicon Endo-Surgery, LLC · 2013

Showing 5 of 50 descendants. See all descendants

Descendants cleared per year

2011high 7 (2019) · low 0 (2015)2026

Class I recalls in this family

K141952 Echelon Flex Powered Vascular Stapler with…cites it directly · 2014
K140560 Echelon Flex Powered Plus Articulating…2 generations on · 2014
K160521 ECHELON FLEX 60 Powered Plus Compact…3 generations on · 2016
K222839 EndoWrist Stapler 30 System, EndoWrist Stapler…4 generations on · 2023

Most influential descendants

Showing 5 of 50 · See all

K110385Echelon Flex 45 / 60 Powered Articulating Endoscopic Linear CutterEthicon Endo-Surgery, Inc. · 2011 · cites it directly27descendants
K112056Echelon 60 Endoscopic Linear Cutter Reload, Black Model ECR60T, Echelon 45 Endoscopic…Ethicon Endo-Surgery, LLC · 2011 · cites it directly25descendants
K130653Echelon Flex 45 Powered Articulating Endoscopic Linear Cutter; Echelon Flex 60 Powered…Ethicon Endo-Surgery, LLC · 2013 · 2 generations on23descendants
K121600Echelon 60 Endoscpic Linear Cutter Reload, WhiteEthicon Endo-Surgery, LLC · 2012 · cites it directly23descendants
K131663Echelon Endoscopic Linear Cutter Reload, BlackEthicon Endo-Surgery, LLC · 2013 · 2 generations on20descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K051002	Endopath Endocutter 60 Endoscopic Linear Cutter	Ethicon Endo-Surgery, Inc.	2005	1
0 (this device)	K081146	Echelon Endoscopic Linear Cutters (Articulating and Straight)	Ethicon Endo-Surgery, LLC	2008	—
+1	K110385	Echelon Flex 45 / 60 Powered Articulating Endoscopic Linear Cutter	Ethicon Endo-Surgery, Inc.	2011	—
+1	K112056	Echelon 60 Endoscopic Linear Cutter Reload, Black Model ECR60T, Echelon 45…	Ethicon Endo-Surgery, LLC	2011	1
+2	K130653	Echelon Flex 45 Powered Articulating Endoscopic Linear Cutter; Echelon Flex 60…	Ethicon Endo-Surgery, LLC	2013	—
+1	K121600	Echelon 60 Endoscpic Linear Cutter Reload, White	Ethicon Endo-Surgery, LLC	2012	—
+2	K131663	Echelon Endoscopic Linear Cutter Reload, Black	Ethicon Endo-Surgery, LLC	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	2	0
2012	2	0
2013	4	0
2014	4	2
2016	3	1
2017	2	0
2018	3	0
2019	7	0
2020	3	0
2021	4	1
2022	3	0
2023	3	1
2024	4	1
2025	4	0
2026	2	0

FIG. 1 — Lineage of K081146, 2005–2026Source: 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.

7 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

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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	Applicant	Decided	Recalls
*	K051002	Endopath Endocutter 60 Endoscopic Linear Cutter Summary page 1 …ass: II Product Code: GDW Predicate Device ENDOPATH Endocutter 60 Endoscopic Linear Cutters (cleared under K051002 and expanded indications cleared under K070887). Device Description The Echelon Endoscopic Linear Cutters (Articulating and Stra…	Ethicon Endo-Surgery, Inc.	2005	1
*	K070887	Endopath Linear Cutters and Staplers and ECHELON60 Endoscopic Linear Cutters and… Summary page 1 …e: GDW Predicate Device ENDOPATH Endocutter 60 Endoscopic Linear Cutters (cleared under K051002 and expanded indications cleared under K070887). Device Description The Echelon Endoscopic Linear Cutters (Articulating and Straight) are sterile, single patient use instrumen…	Ethicon Endo-Surgery, LLC	2007	4

Also cleared against K051002: 5 other devices →

What descends from it? (50)

See all 50

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

Number	Device	Applicant	Decided	Descendants
K110385	Echelon Flex 45 / 60 Powered Articulating Endoscopic Linear Cutter	Ethicon Endo-Surgery, Inc.	2011	27
K112056	Echelon 60 Endoscopic Linear Cutter Reload, Black Model ECR60T, Echelon 45 Endoscopic…	Ethicon Endo-Surgery, LLC	2011	25
K121600	Echelon 60 Endoscpic Linear Cutter Reload, White	Ethicon Endo-Surgery, LLC	2012	23
K120179	Reach Surgical Staplers	Reach Surgical, Inc.	2012	17
K141952	Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath Echelon… Class I	Ethicon Endo-Surgery, Inc.	2014	4
K190331	Applied Medical Laparoscopic Linear Cutter	Applied Medical Resources Corporation	2019	0

Has anything in its family been recalled? (7 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 3, 2019	Class I	Z-0200-2020	Nonconforming Material/Component	The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a…

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 · Cites it directly · ◆ in the 2014 descendants bar of 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 on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
K160521ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mmEthicon Endo-Surgery, LLC · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
K222839EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm…Intuitive Surgical, Inc. · 2023 · 4 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
K2416388mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 ReloadsIntuitive Surgical, Inc. · 2024 · 5 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
K2119978 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 ReloadsIntuitive Surgical, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

Nearest 5 of 6; all are on the web page.

What does this lineage say?

2 of the 2 ancestors have a recall of any class.
Of its descendants, K110385 (Ethicon Endo-Surgery, Inc., 2011) has gone furthest, with 27 descendants of its own.
5 other devices also cite its predicate K051002.

How does its category compare?

All GDW devices

GDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 families of endoscopic linear cutters (articulating and straight) 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/K081146 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081146: Echelon Endoscopic Linear Cutters (Articulating and Straight).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081146

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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