510(k) · Cleared

Cleared

Echelon Gray Cartridge, Model ERC45M

K080839510(k) TraditionalCleared May 21, 200857-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, LLC · GDW Staple, Implantable

Cleared on May 21, 2008 as substantially equivalent to K033269 (Ethicon Endo-Surgery, Inc., 2003) and 2 other predicates after a 57-day review. Its family tree reaches back 1 generation to 2003. 1 later device descends from it.

Decided: May 21, 2008
Review: 57 days
Class: Class II
Product code: GDW
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K033269 (2003). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK033269 Endopath Endocutter Gray Cartridge, Model 6R45M/Gray Cartridge ReloadEthicon Endo-Surgery, Inc. · 2003
This deviceK080839 Echelon Gray Cartridge, Model ERC45MEthicon Endo-Surgery, LLC · 2008
Descendant · cites it directly · 0 of its ownK210909 easyEndo Lite Linear Cutting Stapler and Loading Unit for Single UseEzisurg Medical Co., Ltd. · 2021

Most influential descendants

Showing 1 of 1 · See all

K210909easyEndo Lite Linear Cutting Stapler and Loading Unit for Single UseEzisurg Medical Co., Ltd. · 2021 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K033269	Endopath Endocutter Gray Cartridge, Model 6R45M/Gray Cartridge Reload	Ethicon Endo-Surgery, Inc.	2003	—
0 (this device)	K080839	Echelon Gray Cartridge, Model ERC45M	Ethicon Endo-Surgery, LLC	2008	—
+1	K210909	easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use	Ezisurg Medical Co., Ltd.	2021	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2007	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2021	1	0

FIG. 1 — Lineage of K080839, 2003–2021Source: 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.

Planning a device in GDW? 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? (3)

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
*	K033269	Endopath Endocutter Gray Cartridge, Model 6R45M/Gray Cartridge Reload Summary page 1 …Classification Names: Implantable Staple [21 CFR 878.4750 (GDW)] Predicate Devices ENDOPATH Endocutter Gray Cartridge clear under K033269 on December 10, 2003. ENDOPATH Endocutter 60 Endoscopic Linear Cutter, cleared under K051002 on May 17, 2005. ENDOP…	Ethicon Endo-Surgery, Inc.	2003	—
*	K051002	Endopath Endocutter 60 Endoscopic Linear Cutter Summary page 1 …edicate Devices ENDOPATH Endocutter Gray Cartridge clear under K033269 on December 10, 2003. ENDOPATH Endocutter 60 Endoscopic Linear Cutter, cleared under K051002 on May 17, 2005. ENDOPATH Endocutter 60 Endoscopic Linear Cutter, cleared under K070887 on May 25, 2007. Device Descripti…	Ethicon Endo-Surgery, Inc.	2005	1
*	K070887	Endopath Linear Cutters and Staplers and ECHELON60 Endoscopic Linear Cutters and… Summary page 1 …003. ENDOPATH Endocutter 60 Endoscopic Linear Cutter, cleared under K051002 on May 17, 2005. ENDOPATH Endocutter 60 Endoscopic Linear Cutter, cleared under K070887 on May 25, 2007. Device Description The Echelon devices are sterile, single-use instruments that deliver staples while simultan…	Ethicon Endo-Surgery, LLC	2007	4

Also cleared against K033269: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K210909	easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use	Ezisurg Medical Co., Ltd.	2021	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

2 of the 3 ancestors have a recall of any class.
Of its descendants, K210909 (Ezisurg Medical Co., Ltd., 2021) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K033269.

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 Endoscopic Cutters, Staplers and Reloads are intended for transection, resection, and/or 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/K080839 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080839: Echelon Gray Cartridge, Model ERC45M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080839

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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