510(k) · Cleared

Cleared

Auto Sutur Endo Gia Staplers

K061095510(k) TraditionalCleared May 31, 200642-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

United States Surgical, A Division of Tyco Healthc · GDW Staple, Implantable

Cleared on May 31, 2006 after a 42-day review. The FDA summary names its predicate without a number. 55 later devices descend from it.

Decided: May 31, 2006
Review: 42 days
Class: Class II
Product code: GDW
Recalls: None
Predicates: 0

55 later devices descend from it, 7 citing it directly.

This deviceK061095 Auto Sutur Endo Gia StaplersUnited States Surgical, A Division of Tyco Healthc · 2006
Descendant · cites it directly · 49 of its ownK083519 Autosuture Endo Gia Staplers with Endo Gia Single Use Loading UnitsCovidien Lp, Formerly Registered AS United States · 2009
Descendant · cites it directly · 48 of its ownK080898 Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units…Tyco Healthcare Group LP · 2008 · Recalled
Descendant · 2 generations on · 46 of its ownK101444 Autosuture Endo Gia Single Use Tan Reload with Tri-Staple TechnologySurgical Devices, A Global Business Unit Tyco · 2010
Descendant · cites it directly · 46 of its ownK093410 Autosuture Endo Gia Single Use Black Reload with Tri-Staple TechnologySurgical Devices, A Divsion of Tyco Healthcare · 2009
Descendant · 2 generations on · 45 of its ownK103263 Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H · 2010

Showing 5 of 55 descendants. See all descendants

Descendants cleared per year

2007high 6 (2014) · low 0 (2024)2026

Most influential descendants

Showing 5 of 55 · See all

K083519Autosuture Endo Gia Staplers with Endo Gia Single Use Loading UnitsCovidien Lp, Formerly Registered AS United States · 2009 · cites it directly49descendants
K080898Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line…Tyco Healthcare Group LP · 2008 · cites it directly48descendants
K101444Autosuture Endo Gia Single Use Tan Reload with Tri-Staple TechnologySurgical Devices, A Global Business Unit Tyco · 2010 · 2 generations on46descendants
K093410Autosuture Endo Gia Single Use Black Reload with Tri-Staple TechnologySurgical Devices, A Divsion of Tyco Healthcare · 2009 · cites it directly46descendants
K103263Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H · 2010 · 2 generations on45descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	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	—
+1	K080898	Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with…	Tyco Healthcare Group LP	2008	24
+2	K101444	Autosuture Endo Gia Single Use Tan Reload with Tri-Staple Technology	Surgical Devices, A Global Business Unit Tyco	2010	—
+1	K093410	Autosuture Endo Gia Single Use Black Reload with Tri-Staple Technology	Surgical Devices, A Divsion of Tyco Healthcare	2009	—
+2	K103263	Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE Technology	Covidien, Formerly US Surgical A Divison of Tyco H	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	1	0
2009	2	0
2010	3	0
2011	1	0
2012	4	0
2013	4	0
2014	6	0
2015	3	0
2016	5	0
2017	6	0
2018	2	0
2019	1	0
2020	4	0
2021	4	0
2022	4	0
2023	3	0
2026	1	0

FIG. 1 — Lineage of K061095, 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

Get a 510(k) Report

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
*	—	Auto Suture ENDO GIA Stapler Named without a submission number			—

What descends from it? (55)

See all 55

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

Number	Device	Applicant	Decided	Descendants
K083519	Autosuture Endo Gia Staplers with Endo Gia Single Use Loading Units	Covidien Lp, Formerly Registered AS United States	2009	49
K080898	Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line…	Tyco Healthcare Group LP	2008	48
K093410	Autosuture Endo Gia Single Use Black Reload with Tri-Staple Technology	Surgical Devices, A Divsion of Tyco Healthcare	2009	46
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
K132472	Justright 5MM Stapler, Justright 5MM Reload	Justright Surgical, LLC	2014	0
K130717	Endo Gia Reload	Covidien, Formerly US Surgical A Divison of Tyco H	2013	0
K070930	Reprocessed Autosuture Gia Endoscopic Staplers	Sterilmed, Inc.	2007	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?

Of its descendants, K083519 (Covidien Lp, Formerly Registered AS United States, 2009) has gone furthest, with 49 descendants of its own.

How does its category compare?

All GDW devices

GDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 Auto Suture ENDO GIA Staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomoses. 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/K061095 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061095: Auto Sutur Endo Gia Staplers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061095

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