510(k) · Cleared

Cleared

Autosuture Circular Eea Surgical Staplers

K062850510(k) SpecialCleared Oct 23, 200628-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 Oct 23, 2006 as substantially equivalent to K024275 (United States Surgical, A Division of Tyco Healthc, 2003) after a 28-day review. Its family tree reaches back 1 generation to 2003. 17 later devices descend from it.

Decided: Oct 23, 2006
Review: 28 days
Class: Class II
Product code: GDW
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K024275 (2003). 17 later devices descend from it, 8 citing it directly.

By dateBy generation

Root · 1 generation backK024275 Auto Suture Premium Plus Ceea Disposable StaplerUnited States Surgical, A Division of Tyco Healthc · 2003
This deviceK062850 Autosuture Circular Eea Surgical StaplersUnited States Surgical, A Division of Tyco Healthc · 2006
Descendant · cites it directly · 10 of its ownK172361 EEA Circular Stapler with Tri-Staple TechnologyCovidien · 2018 · Recalled
Descendant · cites it directly · 8 of its ownK192330 EEA Circular Stapler with Tri-Staple TechnologyCovidien · 2020
Descendant · 2 generations on · 5 of its ownK202507 EEA Circular Stapler with Tri-Staple TechnologyCovidien · 2021
Descendant · 2 generations on · 4 of its ownK221005 EEA Circular Stapler with Tri-Staple TechnologyCovidien · 2022
Descendant · 2 generations on · 3 of its ownK182475 Signia Circular Adapters (for use with Signia Staplers), Tri-Staple…Covidien · 2019

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2009high 3 (2022) · low 0 (2010)2026

Most influential descendants

Showing 5 of 17 · See all

K172361EEA Circular Stapler with Tri-Staple TechnologyCovidien · 2018 · cites it directly10descendants
K192330EEA Circular Stapler with Tri-Staple TechnologyCovidien · 2020 · cites it directly8descendants
K202507EEA Circular Stapler with Tri-Staple TechnologyCovidien · 2021 · 2 generations on5descendants
K221005EEA Circular Stapler with Tri-Staple TechnologyCovidien · 2022 · 2 generations on4descendants
K182475Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads…Covidien · 2019 · 2 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K024275	Auto Suture Premium Plus Ceea Disposable Stapler	United States Surgical, A Division of Tyco Healthc	2003	—
0 (this device)	K062850	Autosuture Circular Eea Surgical Staplers	United States Surgical, A Division of Tyco Healthc	2006	—
+1	K172361	EEA Circular Stapler with Tri-Staple Technology	Covidien	2018	1
+1	K192330	EEA Circular Stapler with Tri-Staple Technology	Covidien	2020	—
+2	K202507	EEA Circular Stapler with Tri-Staple Technology	Covidien	2021	—
+2	K221005	EEA Circular Stapler with Tri-Staple Technology	Covidien	2022	—
+2	K182475	Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0…	Covidien	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	2	0
2011	1	0
2016	1	0
2017	1	0
2018	1	0
2019	1	0
2020	1	0
2021	2	0
2022	3	0
2023	2	0
2024	1	0
2026	1	0

FIG. 1 — Lineage of K062850, 2003–2026Source: 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? (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
*	K024275	Auto Suture Premium Plus Ceea Disposable Stapler Summary page 1 …Implantable Staple CLASSIFICATION NAME: Implantable Staple PREDICATE DEVICE(S): autosutureTM Premium Plus CEEATm Disposable Stapler (K024275) DEVICE DESCRIPTION: The autosuture TM Circular EEATM family of staplers place a c…	United States Surgical, A Division of Tyco Healthc	2003	—

Also cleared against K024275: 4 other devices →

What descends from it? (17)

See all 17

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

Number	Device	Applicant	Decided	Descendants
K172361	EEA Circular Stapler with Tri-Staple Technology	Covidien	2018	10
K192330	EEA Circular Stapler with Tri-Staple Technology	Covidien	2020	8
K103470	Panther Group of Surgical Includes: Oanther Circular Stapler; Panther Hemorrhoidal…	B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.	2011	1
K221003	Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture…	Covidien	2022	0
K162947	Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting…	Chongqing Qmi Surgical Co., Ltd.	2017	0
K160969	ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler	Shinemed, LLC	2016	0
K093402	Autosuture Eea Orvil	Surgical Devices, A Global Business Unit Tyco	2009	0
K083781	Eea Hemorrhoid Stapler & Accessories	Surgical Devices, A Global Business Unit Covidien	2009	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?

Its one ancestor has no recall.
Of its descendants, K172361 (Covidien, 2018) has gone furthest, with 10 descendants of its own.
4 other devices also cite its predicate K024275.

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 autosuture T M Circular EEATM Staplers have application throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries, including bariatric surgery.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062850 · printed Nov 4, 2026

Cite this page

510(k) Report. “K062850: Autosuture Circular Eea Surgical Staplers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062850

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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