510(k) · Cleared

Cleared

Echelon Flex 45 / 60 Powered Articulating Endoscopic Linear Cutter

K110385510(k) TraditionalCleared Mar 25, 201143-day reviewClass II21 CFR 878.4750

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 Mar 25, 2011 as substantially equivalent to K081146 (Ethicon Endo-Surgery, LLC, 2008) after a 43-day review. Its family tree reaches back 2 generations to 2005. 7 of the 31 devices in its family, counting itself, have a Class I recall. 27 later devices descend from it.

Decided: Mar 25, 2011
Review: 43 days
Class: Class II
Product code: GDW
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K051002 (2005). 3 ancestors in all. 27 later devices descend from it, 3 citing it directly. 7 of the 31 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 2 generations backK051002 Endopath Endocutter 60 Endoscopic Linear CutterEthicon Endo-Surgery, Inc. · 2005 · Recalled
1 generation backK081146 Echelon Endoscopic Linear Cutters (Articulating and Straight)Ethicon Endo-Surgery, LLC · 2008 · Recalled (Class I)
This deviceK110385 Echelon Flex 45 / 60 Powered Articulating Endoscopic Linear CutterEthicon Endo-Surgery, Inc. · 2011
Descendant · cites it directly · 23 of its ownK130653 Echelon Flex 45 Powered Articulating Endoscopic Linear Cutter…Ethicon Endo-Surgery, LLC · 2013
Descendant · cites it directly · 19 of its ownK140560 Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter…Ethicon Endo-Surgery, LLC · 2014 · Recalled (Class I)
Descendant · 2 generations on · 9 of its ownK160521 ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear…Ethicon Endo-Surgery, LLC · 2016 · Recalled (Class I)
Descendant · 2 generations on · 8 of its ownK163454 ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear…Ethicon Endo-Surgery, LLC · 2017 · Recalled
Descendant · 2 generations on · 6 of its ownK173721 SureForm 60 and SureForm 60 ReloadsIntuitive Surgical · 2018 · Recalled

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2013high 5 (2019) · low 0 (2015)2026

Class I recalls in this family

K081146 Echelon Endoscopic Linear Cutters (Articulating…direct predicate · 2008
K141952 Echelon Flex Powered Vascular Stapler with…cites it directly · 2014
K140560 Echelon Flex Powered Plus Articulating…cites it directly · 2014
K160521 ECHELON FLEX 60 Powered Plus Compact…2 generations on · 2016

Most influential descendants

Showing 5 of 27 · See all

K130653Echelon Flex 45 Powered Articulating Endoscopic Linear Cutter; Echelon Flex 60 Powered…Ethicon Endo-Surgery, LLC · 2013 · cites it directly23descendants
K140560Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter, 60MM, Standard, Echelon…Ethicon Endo-Surgery, LLC · 2014 · cites it directly19descendants
K160521ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mmEthicon Endo-Surgery, LLC · 2016 · 2 generations on9descendants
K163454ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH…Ethicon Endo-Surgery, LLC · 2017 · 2 generations on8descendants
K173721SureForm 60 and SureForm 60 ReloadsIntuitive Surgical · 2018 · 2 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K051002	Endopath Endocutter 60 Endoscopic Linear Cutter	Ethicon Endo-Surgery, Inc.	2005	1
−1	K081146	Echelon Endoscopic Linear Cutters (Articulating and Straight)	Ethicon Endo-Surgery, LLC	2008	Class I
0 (this device)	K110385	Echelon Flex 45 / 60 Powered Articulating Endoscopic Linear Cutter	Ethicon Endo-Surgery, Inc.	2011	—
+1	K130653	Echelon Flex 45 Powered Articulating Endoscopic Linear Cutter; Echelon Flex 60…	Ethicon Endo-Surgery, LLC	2013	—
+1	K140560	Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter, 60MM…	Ethicon Endo-Surgery, LLC	2014	Class I
+2	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
+2	K173721	SureForm 60 and SureForm 60 Reloads	Intuitive Surgical	2018	3

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
2013	1	0
2014	2	2
2016	1	1
2017	1	0
2018	1	0
2019	5	0
2020	2	0
2021	3	1
2022	2	0
2023	1	1
2024	3	1
2025	3	0
2026	2	0

FIG. 1 — Lineage of K110385, 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 15.1 · 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? (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	Applicant	Decided	Recalls
*	K081146	Echelon Endoscopic Linear Cutters (Articulating and Straight)	Ethicon Endo-Surgery, LLC	2008	Class I

Also cleared against K081146: 5 other devices →

What descends from it? (27)

See all 27

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

Number	Device	Applicant	Decided	Descendants
K130653	Echelon Flex 45 Powered Articulating Endoscopic Linear Cutter; Echelon Flex 60 Powered…	Ethicon Endo-Surgery, LLC	2013	23
K140560	Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter, 60MM, Standard, Echelon… Class I	Ethicon Endo-Surgery, LLC	2014	19
K141952	Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath Echelon… Class I	Ethicon Endo-Surgery, Inc.	2014	4

Has anything in its family been recalled? (7 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.

K081146Echelon Endoscopic Linear Cutters (Articulating and Straight)Ethicon Endo-Surgery, LLC · 2008 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
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 · Cites it directly · ◆ 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 · 2 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 · 3 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 · 4 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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

Nearest 5 of 7; all are on the web page.

What does this lineage say?

The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
3 of the 3 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K130653 (Ethicon Endo-Surgery, LLC, 2013) has gone furthest, with 23 descendants of its own.
5 other devices also cite its predicate K081146.

How does its category compare?

All GDW devices

GDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 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/K110385 · printed Nov 3, 2026

Cite this page

510(k) Report. “K110385: Echelon Flex 45 / 60 Powered Articulating Endoscopic Linear Cutter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K110385

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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