510(k) · Cleared

Cleared

Seamguard Staple Line Reinforcement Material

K001789510(k) TraditionalCleared Jul 6, 200023-day reviewClass II21 CFR 878.3300

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

W. L. Gore & Associates, Inc. · OXD Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement

Cleared on Jul 6, 2000 after a 23-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 210 later devices descend from it.

Decided: Jul 6, 2000
Review: 23 days
Class: Class II
Product code: OXD
Recalls: None
Predicates: 0

210 later devices descend from it, 4 citing it directly.

This deviceK001789 Seamguard Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2000
Descendant · cites it directly · 145 of its ownK014183 Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002
Descendant · cites it directly · 143 of its ownK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
Descendant · 2 generations on · 102 of its ownK032865 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
Descendant · 2 generations on · 77 of its ownK043056 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2004
Descendant · cites it directly · 75 of its ownK042026 Bard CK Parastomal Hernia Patch, Models 0118001, 0118002, 0118003…C.R. Bard, Inc. · 2004

Showing 5 of 210 descendants. See all descendants

Descendants cleared per year

2002high 21 (2017) · low 1 (2006)2026

Most influential descendants

Showing 5 of 210 · See all

K014183Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002 · cites it directly145descendants
K030782Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003 · cites it directly143descendants
K032865Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003 · 2 generations on102descendants
K043056Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2004 · 2 generations on77descendants
K042026Bard CK Parastomal Hernia Patch, Models 0118001, 0118002, 0118003, 0118004C.R. Bard, Inc. · 2004 · cites it directly75descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K001789	Seamguard Staple Line Reinforcement Material	W. L. Gore & Associates, Inc.	2000	—
+1	K014183	Afb (Absorbable Foam Buttress)	J&J Corporate Biomaterials Center	2002	—
+1	K030782	Seamguard Bioabsorbable Staple Line Reinforcement Material	W. L. Gore & Associates, Inc.	2003	—
+2	K032865	Gore Seamguard Bioabsorbable Staple Line Reinforcement Material	W. L. Gore & Associates, Inc.	2003	—
+2	K043056	Gore Seamguard Bioabsorbable Staple Line Reinforcement Material	W. L. Gore & Associates, Inc.	2004	—
+1	K042026	Bard CK Parastomal Hernia Patch, Models 0118001, 0118002, 0118003, 0118004	C.R. Bard, Inc.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	3	0
2003	3	0
2004	4	0
2005	4	0
2006	1	0
2007	6	0
2008	9	0
2009	3	0
2010	4	0
2011	6	0
2012	13	0
2013	16	0
2014	15	0
2015	8	0
2016	16	0
2017	21	0
2018	12	0
2019	7	0
2020	7	0
2021	7	0
2022	13	0
2023	10	0
2024	5	0
2025	7	0
2026	10	0

FIG. 1 — Lineage of K001789, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OXD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (210)

See all 210

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

Number	Device	Applicant	Decided	Descendants
K014183	Afb (Absorbable Foam Buttress)	J&J Corporate Biomaterials Center	2002	145
K030782	Seamguard Bioabsorbable Staple Line Reinforcement Material	W. L. Gore & Associates, Inc.	2003	143
K042026	Bard CK Parastomal Hernia Patch, Models 0118001, 0118002, 0118003, 0118004	C.R. Bard, Inc.	2004	75
K022350	Bard Crurasoft Patch, Models 0116003 & 0116001	C.R. Bard, Inc.	2002	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, K014183 (J&J Corporate Biomaterials Center, 2002) has gone furthest, with 145 descendants of its own.

How does its category compare?

All OXD devices

OXD Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OXD

FDA has decided no OXD device since 2007.

Median 510(k) review, days · OXD

Too few OXD 510(k)s in any year since 2007 to give a median.

Recalls per year · OXD

No recall names OXD since 2007.

Adverse event reports per year · OXD

3in 2025

2007high 3 (2024) · low 0 (2007)2025

MAUDE reports naming product code OXD, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	3
2025	—	3
2026	—	—

https://510kreport.com/device/K001789 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001789: Seamguard Staple Line Reinforcement Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001789

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026