510(k) · Cleared

Cleared

Covidien Endo Gia Radial Reload with Tri-Staple Technology

K102291510(k) TraditionalCleared Sep 15, 201034-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

Covidien · GDW Staple, Implantable

Cleared on Sep 15, 2010 as substantially equivalent to K083519 (Covidien Lp, Formerly Registered AS United States, 2009) and 1 other predicate after a 34-day review. Its family tree reaches back 4 generations to 1984. 45 later devices descend from it.

Decided: Sep 15, 2010
Review: 34 days
Class: Class II
Product code: GDW
Recalls: None
Predicates: 2

Its longest line of descent runs back 4 generations to K843034 (1984). 8 ancestors in all. 45 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 4 generations backK843034 Disposable Linear CutterETHICON, Inc. · 1984
3 generations backK040038 Curved Cutter Stapler, Models CS40B, CS40G; Reload for Curved…Ethicon Endo-Surgery, Inc. · 2004
2 generations backK062869 Contour Curved Cutter Stapler and Reloads, Models CS40B, CS40G…Ethicon Endo-Surgery, LLC · 2007
1 generation backK091322 Contour Curved Cutter Stapler and Reloads, Models: CS40B, CS40G…Ethicon Endo-Surgery, Inc. · 2009
This deviceK102291 Covidien Endo Gia Radial Reload with Tri-Staple TechnologyCovidien · 2010
Descendant · cites it directly · 44 of its ownK111825 Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · Recalled
Descendant · 2 generations on · 8 of its ownK121510 Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H · 2012
Descendant · 3 generations on · 5 of its ownK160176 Signia StaplerCovidien · 2016 · Recalled
Descendant · 2 generations on · 3 of its ownK192720 GIA Stapler with Tri-Staple TechnologyCovidien · 2020
Descendant · 2 generations on · 3 of its ownK161757 Single Use Curved Cutters, Single Use Circular Staplers, Single Use…Victor Medical Instruments Co., Ltd. · 2016

Showing 5 of 45 descendants. See all descendants

Descendants cleared per year

2011high 6 (2017) · low 0 (2024)2026

Most influential descendants

Showing 5 of 45 · See all

K111825Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM)…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · cites it directly44descendants
K121510Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H · 2012 · 2 generations on8descendants
K160176Signia StaplerCovidien · 2016 · 3 generations on5descendants
K192720GIA Stapler with Tri-Staple TechnologyCovidien · 2020 · 2 generations on3descendants
K161757Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and…Victor Medical Instruments Co., Ltd. · 2016 · 2 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K843034	Disposable Linear Cutter	ETHICON, Inc.	1984	—
−3	K040038	Curved Cutter Stapler, Models CS40B, CS40G; Reload for Curved Stapler, Models…	Ethicon Endo-Surgery, Inc.	2004	—
−2	K062869	Contour Curved Cutter Stapler and Reloads, Models CS40B, CS40G, CR40B and CR40G	Ethicon Endo-Surgery, LLC	2007	—
−1	K091322	Contour Curved Cutter Stapler and Reloads, Models: CS40B, CS40G, CR40B, CR40G	Ethicon Endo-Surgery, Inc.	2009	—
0 (this device)	K102291	Covidien Endo Gia Radial Reload with Tri-Staple Technology	Covidien	2010	—
+1	K111825	Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA…	Covidien, Formerly US Surgical A Divison of Tyco H	2011	73
+2	K121510	Idrive Ultra Powered Handle Endo Gia Adapter	Covidien, Formerly US Surgical A Divison of Tyco H	2012	—
+3	K160176	Signia Stapler	Covidien	2016	14
+2	K192720	GIA Stapler with Tri-Staple Technology	Covidien	2020	—
+2	K161757	Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear…	Victor Medical Instruments Co., Ltd.	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
2006	2	0
2009	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2012	4	0
2013	4	0
2014	5	0
2015	2	0
2016	5	0
2017	6	0
2018	2	0
2019	1	0
2020	4	0
2021	3	0
2022	4	0
2023	3	0
2026	1	0

FIG. 1 — Lineage of K102291, 1984–2026Source: 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.

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 15.1 · 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? (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
*	K083519	Autosuture Endo Gia Staplers with Endo Gia Single Use Loading Units Summary page 1 …Surgical Stapler with Implantable Staple CLASSIFICATION NAME: Staple, Implantable PREDICATE DEVICE(S): IAutosuture T M ENDO GIA TM Stapler (K083519), Ethicon Contour Curved Cutter Stapler & Reloads (K091322) DEVICE DESCRIPTION: The Endo GIA…	Covidien Lp, Formerly Registered AS United States	2009	—
*	K091322	Contour Curved Cutter Stapler and Reloads, Models: CS40B, CS40G, CR40B, CR40G Summary page 1 …ble PREDICATE DEVICE(S): IAutosuture T M ENDO GIA TM Stapler (K083519), Ethicon Contour Curved Cutter Stapler & Reloads (K091322) DEVICE DESCRIPTION: The Endo GIA TM Radial Reload with Tni-Staple TM Technology is a curved stapler cartridge that places three…	Ethicon Endo-Surgery, Inc.	2009	—

Also cleared against K083519: 5 other devices →

What descends from it? (45)

See all 45

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

Number	Device	Applicant	Decided	Descendants
K111825	Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM)…	Covidien, Formerly US Surgical A Divison of Tyco H	2011	44
K131705	Endo Gia Radial Reload with Tri-Staple Technology	Covidien, Formerly US Surgical A Divison of Tyco H	2013	1

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?

The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
1 of the 8 ancestors has a recall of any class.
Of its descendants, K111825 (Covidien, Formerly US Surgical A Divison of Tyco H, 2011) has gone furthest, with 44 descendants of its own.
5 other devices also cite its predicate K083519.

How does its category compare?

All GDW devices

GDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Endo GIA TM Radial Reload with Tri-StapleTm Technology has application in open or minimally invasive general abdominal, gynecologic, pediatric and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, i.e. low anterior resection.

It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K102291 · printed Nov 4, 2026

Cite this page

510(k) Report. “K102291: Covidien Endo Gia Radial Reload with Tri-Staple Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K102291

Report an extraction error

Are you the manufacturer?

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