510(k) · Cleared

Cleared

Modified Endo Stich

K082659510(k) SpecialCleared Sep 19, 20087-day reviewClass II21 CFR 876.1500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Covidien Lp, Formerly Registered AS United States · OCW Endoscopic Tissue Approximation Device

Cleared on Sep 19, 2008 as substantially equivalent to K934738 (United States Surgical, A Division of Tyco Healthc, 1994) after a 7-day review. Its family tree reaches back 1 generation to 1994. 50 later devices descend from it.

Decided: Sep 19, 2008
Review: 7 days
Class: Class II
Product code: OCW
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K934738 (1994). 50 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK934738 Autosuture Endoscopic Suturing DeviceUnited States Surgical, A Division of Tyco Healthc · 1994 · Recalled
This deviceK082659 Modified Endo StichCovidien Lp, Formerly Registered AS United States · 2008
Descendant · cites it directly · 47 of its ownK090419 Sils Stitch Endoscopic Suturing DeviceCovidien Lp, Formerly Registered AS United States · 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
Descendant · 3 generations on · 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 · 4 generations on · 8 of its ownK121510 Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H · 2012
Descendant · 5 generations on · 5 of its ownK160176 Signia StaplerCovidien · 2016 · Recalled

Showing 5 of 50 descendants. See all descendants

Descendants cleared per year

2009high 6 (2016) · low 0 (2024)2026

Most influential descendants

Showing 5 of 50 · See all

K090419Sils Stitch Endoscopic Suturing DeviceCovidien Lp, Formerly Registered AS United States · 2009 · cites it directly47descendants
K103263Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H · 2010 · 2 generations on45descendants
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 · 3 generations on44descendants
K121510Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H · 2012 · 4 generations on8descendants
K160176Signia StaplerCovidien · 2016 · 5 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K934738	Autosuture Endoscopic Suturing Device	United States Surgical, A Division of Tyco Healthc	1994	2
0 (this device)	K082659	Modified Endo Stich	Covidien Lp, Formerly Registered AS United States	2008	—
+1	K090419	Sils Stitch Endoscopic Suturing Device	Covidien Lp, Formerly Registered AS United States	2009	—
+2	K103263	Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE Technology	Covidien, Formerly US Surgical A Divison of Tyco H	2010	—
+3	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
+4	K121510	Idrive Ultra Powered Handle Endo Gia Adapter	Covidien, Formerly US Surgical A Divison of Tyco H	2012	—
+5	K160176	Signia Stapler	Covidien	2016	14

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2010	1	0
2011	2	0
2012	4	0
2013	4	0
2014	5	0
2015	2	0
2016	6	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 K082659, 1994–2026Source: 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 OCW? 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 OCW device

#1 K252400 Endomina EZFuse systemscore 12.0 · 5 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
*	K934738	Autosuture Endoscopic Suturing Device Summary page 1 …Endoscopic Suturing Device CLASSIFICATION NAME: Endoscope and accessories PREDICATE DEVICE(S): K934738: AutosutureTM Endoscopic Suturing Device DEVICE DESCRIPTION:…	United States Surgical, A Division of Tyco Healthc	1994	2

Also cleared against K934738: 3 other devices →

What descends from it? (50)

See all 50

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

Number	Device	Applicant	Decided	Descendants
K090419	Sils Stitch Endoscopic Suturing Device	Covidien Lp, Formerly Registered AS United States	2009	47
K201744	Su2ura Approximation Device	Anchora Medical, Ltd.	2021	0
K153611	Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND…	Ethicon, LLC	2016	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 a recall.
Of its descendants, K090419 (Covidien Lp, Formerly Registered AS United States, 2009) has gone furthest, with 47 descendants of its own.
3 other devices also cite its predicate K934738.

How does its category compare?

All OCW devices

OCW Endoscopic Tissue Approximation Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · OCW

1in 2025

2007high 5 (2007) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OCW

133in 2023

2007high 221 (2021) · low 30 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OCW

3so far in 2026, the most since 2007

2007high 3 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OCW

326in 2025

2007high 420 (2017) · low 2 (2013)2025

MAUDE reports naming product code OCW, 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	5	58	0	9
2008	4	70	0	47
2009	3	30	0	30
2010	4	91	0	10
2011	1	—	0	16
2012	1	—	0	28
2013	2	—	0	2
2014	0	—	0	28
2015	0	—	0	59
2016	2	—	0	74
2017	2	—	0	420
2018	2	—	0	413
2019	1	—	0	291
2020	1	—	0	183
2021	3	221	0	198
2022	0	—	0	235
2023	3	133	1	227
2024	0	—	0	211
2025	1	—	0	326
2026	2	—	3	—

What is it indicated for?

The Modified Endo StitchTM 10 mm single use suturing device has application in endoscopic surgery for the placement of interrupted or running stitches in soft tissues

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082659 · printed Nov 5, 2026

Cite this page

510(k) Report. “K082659: Modified Endo Stich.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082659

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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