510(k) · Cleared

Cleared

Autosuture Eea Orvil

K093402510(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 Global Business Unit Tyco · GDW Staple, Implantable

Cleared on Nov 12, 2009 as substantially equivalent to K024275 (United States Surgical, A Division of Tyco Healthc, 2003) and 1 other predicate after a 10-day review. Its family tree reaches back 2 generations to 2003.

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 K024275 (2003). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK024275 Auto Suture Premium Plus Ceea Disposable StaplerUnited States Surgical, A Division of Tyco Healthc · 2003
1 generation backK062850 Autosuture Circular Eea Surgical StaplersUnited States Surgical, A Division of Tyco Healthc · 2006
This deviceK093402 Autosuture Eea OrvilSurgical Devices, A Global Business Unit Tyco · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K024275	Auto Suture Premium Plus Ceea Disposable Stapler	United States Surgical, A Division of Tyco Healthc	2003	—
−1	K062850	Autosuture Circular Eea Surgical Staplers	United States Surgical, A Division of Tyco Healthc	2006	—
0 (this device)	K093402	Autosuture Eea Orvil	Surgical Devices, A Global Business Unit Tyco	2009	—

FIG. 1 — Lineage of K093402, 2003–2009Source: 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? (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
*	K024275	Auto Suture Premium Plus Ceea Disposable Stapler Summary page 1 …Stapler Anvil Accessory CLASSIFICATION NAME: Implantable Staple PREDICATE DEVICE(S): K024275: Autosuturem Premium Plus 6EEA~h (Note: There are no modifications Disposable Stapler to the previous…	United States Surgical, A Division of Tyco Healthc	2003	—
*	K062850	Autosuture Circular Eea Surgical Staplers Summary page 1 …(Note: There are no modifications Disposable Stapler to the previously cleared devices.) K062850: Autosuture~ EEA Surgical Staplerms DEVICE DESCRIPTION: The DST Series~m EEA~m 21, 25 or 28…	United States Surgical, A Division of Tyco Healthc	2006	—

Also cleared against K024275: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 6 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
None of the 2 ancestors has a recall.
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. 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 DST Series TM EEATM OrViITM 21 mm device when used with the DST Series TM EEATM 21 mm stapler, the DST Series TM EEATM OrViITM 25 mm device when used with the DST SeriesTM EEATM 25mm stapler, and the DST Series TM EEATM OrViITM 28 mm device when used with the DST SerieSTMEEATM 28 mm stapler has applications 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/K093402 · printed Nov 6, 2026

Cite this page

510(k) Report. “K093402: Autosuture Eea Orvil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093402

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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