510(k) · Cleared

Cleared

Autosuture Endo Gia Single Use Black Reload with Tri-Staple Technology

K093410510(k) SpecialCleared Nov 12, 200910-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

Surgical Devices, A Divsion of Tyco Healthcare · GDW Staple, Implantable

Cleared on Nov 12, 2009 as substantially equivalent to K083519 (Covidien Lp, Formerly Registered AS United States, 2009) and 1 other predicate after a 10-day review. Its family tree reaches back 2 generations to 2006. 46 later devices descend from it.

Decided: Nov 12, 2009
Review: 10 days
Class: Class II
Product code: GDW
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K061095 (2006). 46 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 2 generations backK061095 Auto Sutur Endo Gia StaplersUnited States Surgical, A Division of Tyco Healthc · 2006
1 generation backK083519 Autosuture Endo Gia Staplers with Endo Gia Single Use Loading UnitsCovidien Lp, Formerly Registered AS United States · 2009
This deviceK093410 Autosuture Endo Gia Single Use Black Reload with Tri-Staple TechnologySurgical Devices, A Divsion of Tyco Healthcare · 2009
Descendant · cites it directly · 45 of its ownK103263 Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H · 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

Showing 5 of 46 descendants. See all descendants

Descendants cleared per year

2010high 6 (2017) · low 0 (2024)2026

Most influential descendants

Showing 5 of 46 · See all

K103263Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H · 2010 · cites it directly45descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K061095	Auto Sutur Endo Gia Staplers	United States Surgical, A Division of Tyco Healthc	2006	—
−1	K083519	Autosuture Endo Gia Staplers with Endo Gia Single Use Loading Units	Covidien Lp, Formerly Registered AS United States	2009	—
0 (this device)	K093410	Autosuture Endo Gia Single Use Black Reload with Tri-Staple Technology	Surgical Devices, A Divsion of Tyco Healthcare	2009	—
+1	K103263	Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE Technology	Covidien, Formerly US Surgical A Divison of Tyco H	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	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
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 K093410, 2006–2026Source: 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

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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
*	K083519	Autosuture Endo Gia Staplers with Endo Gia Single Use Loading Units Summary page 1 …Stapler with Implantable Staples CLASSIFICATION NAME: Staples, Implantable PREDICATE DEVICE(S): AutosutureTM Endo GIATM Stapler (K083519; K061095) DEVICE DESCRIPTION: This 510(k) shall describe a new Reload cartridge with Tri-…	Covidien Lp, Formerly Registered AS United States	2009	—
*	K061095	Auto Sutur Endo Gia Staplers Summary page 1 …with Implantable Staples CLASSIFICATION NAME: Staples, Implantable PREDICATE DEVICE(S): AutosutureTM Endo GIATM Stapler (K083519; K061095) DEVICE DESCRIPTION: This 510(k) shall describe a new Reload cartridge with Tri-…	United States Surgical, A Division of Tyco Healthc	2006	—

Also cleared against K083519: 5 other devices →

What descends from it? (46)

See all 46

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

Number	Device	Applicant	Decided	Descendants
K103263	Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE Technology	Covidien, Formerly US Surgical A Divison of Tyco H	2010	45
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
K132493	Endo Gia Radial Reload with Tri-Staple Technology	Covidien, LLC	2013	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?

The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K103263 (Covidien, Formerly US Surgical A Divison of Tyco H, 2010) has gone furthest, with 45 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. 2009, 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 AutosutureTM Endo GIA TM Staplers with Endo GIATM Single Use Reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They 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/K093410 · printed Nov 4, 2026

Cite this page

510(k) Report. “K093410: Autosuture Endo Gia Single Use Black 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/K093410

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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